Carprofen

Carprofen is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries In dogs.

For use in dogs only. Do not use in cats. Carprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.

CARPRIEVE®

For the control of postoperative pain associated with soft tissue and orthopedic surgery. For the relief of pain and inflammation associated with osteoarthritis.

For use in dogs only. Not for use in cats. For the control of postoperative pain, administer approximately 2 hours before the procedure. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Rimadyl® Caplets

For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. <span style="font-size: 10pt; font-family: 'Verdana','sans-serif'; line-height: 115%; mso-fareast-font-family: Calibri; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Carprieve® Injection

INDICATIONS: Flexprofen Tablets are indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

Flexprofen® (carprofen) Tablets

Carprofen Injectable is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

CarprofenSterile Injectable Solution 50 mg/mLNon-steroidal anti-inflammatory drugFor subcutaneous use in dogs only

For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries

Federal Law restricts this drug to use by or on the order of a licensed veterinarian

Carprofen Chewable Tablets

CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models.1 The mechanism of action of carprofen, like that of other NSAlDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals.2 The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to species.3 In an in vitro study using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1.4 Clinical relevance of these data has not been shown. Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.1 Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses. 5-9 Data also indicate that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effects on prostaglandin biosynthesis.1 Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered orally.10 Peak blood plasma concentrations are achieved in 1–3 hours after oral administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5–9.8 hours) after single oral doses varying from 1-35 mg/kg of body weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carprofen is more than 99% bound to plasma protein and exhibits a very small volume of distribution. Comparison of a single 25 mg dose in Beagle dogs after subcutaneous and oral administration demonstrated that the dorsoscapular subcutaneous administration results in a slower rate of drug input (as reflected by mean peak observed concentrations) but comparable total drug absorption within a 12 hour dosing interval (as reflected by area under the curve from hours zero to 12 postdose). Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70–80%) and urine (10–20%). Some enterohepatic circulation of the drug is observed.

Carprovet® (carprofen)Sterile Injectable Solution50 mg/mL

CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models.1

TruProfen(Carprofen) Flavored Tablets

CONTRAINDICATIONS: Flexprofen Tablets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Flexprofen® (carprofen) Tablets

Carprofen Soft Chewable Tablets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

CARPROFEN Soft Chewable Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

Levafen™ (carprofen) Tablets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Levafen™ (carprofen) Tablets Flavored Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

Flexprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Flexprofen® (carprofen) Sterile Injectable Solution 50 mg/mL

WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience). Keep Flexprofen Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Flexprofen® (carprofen) Tablets

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience). Keep Levafen™ (carprofen) Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Levafen™ (carprofen) Tablets Flavored Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. Keep Carprovet Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience).

Carprovet® (carprofen tablets) Flavored Tablets

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. Keep Vetprofen Flavored Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see INFORMATION FOR DOG OWNERS, ADVERSE REACTIONS, ANIMAL SAFETY and POST-APPROVAL EXPERIENCE).

Vetprofen® (Carprofen Flavored Tablets) Non-steroidal anti-inflammatory drug For oral use in dogs only

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. Keep Novox Flavored Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience).

Novox®(Carprofen flavored tablets) For oral use in dogs only Non-Steroidal Anti-inflammatory Drug

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs only. Do not use in cats. Keep Ostifen in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and Post-Approval Experience).

FDA application 200-498

WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental human exposure. For use in dogs only. Do not use in cats. All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions, Animal Safety and Post-Approval Experience).

Carprovet® (carprofen)Sterile Injectable Solution50 mg/mL

Non-steroidal anti-inflammatory drug For Oral Use In Dogs Only CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

TruProfen(Carprofen) Flavored Tablets

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Carprovet® (carprofen)Sterile Injectable Solution50 mg/mL

During investigational studies for the caplet formulation with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2mg/lb once daily) Observation Carprofen (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 - SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily) Observation* Carprofen (n=148) Placebo (n=149) Vomiting 10.1 13.4 Diarrhea/soft stool 6.1 6.0 Ocular disease 2.7 0 Inappetence 1.4 0 Dermatitis/Skin lesion 2.0 1.3 Dysrhythmia 0.7 0 Apnea 1.4 0 Oral/Periodontal disease 1.4 0 Pyrexia 0.7 1.3 Urinary tract disease 1.4 1.3 Wound drainage 1.4 0 *A single dog may have experienced more than one occurrence of an event During investigational studies for the chewable tablet formulation, gastrointestinal signs were observed in some dogs. These signs included vomiting and soft stools. Post-Approval Experience: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system. Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis. Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers. Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation. Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria. Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness. Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis. Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis. Immunologic or hypersensitivity: Facial swelling, hives, erythema. In rare situations, death has been associated with some of the adverse reactions listed above. Contact Information: Contact Cronus Pharma LLC at 1-844-227-6687 and 1-844-2-CRONUS or https://cronuspharma.com. To report suspected adverse drug experiences, contact Cronus Pharma LLC at 1-844-227-6687 and 1-844-2-CRONUS. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Carprofen Chewable Tablets (carprofen) Non-steroidal anti-inflammatory drug For oral use in dogs only

During investigational studies for the caplet formulation, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen- and placebo- treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1 .4%), behavioral changes (1 %), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies with once daily oral administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily) Observation Carprofen (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 -- SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; the use of clinical judgement is necessary to determine clinical relevance (refers also to table below). There were no serious adverse events reported during clinical field studies for the injectable formulation. The following categories of abnormal health observations were reported. Saline served as placebo control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Studies with the Injectable Observation* Carprofen (n=168) Placebo (n=163) Vomiting 10.1 9.2 Diarrhea/soft stool 2.4 3.7 Dermatitis 0.6 1.2 Dysrhythmia 0.6 0.6 Swelling 0 1.2 Dehiscence 1.2 0 WBC increase 13.7 6.7 *A single dog may have experienced more than one occurrence of an event. Post-Approval Experience Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed by body system. Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis. Hepatic: lnappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers. Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation. Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria. Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness. Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis. Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis. In rare situations, injection site reactions including necrosis, abscess and seroma formation, and granulomas have been reported with the injectable formulation. Immunologic or hypersensitivity: Facial swelling, hives, erythema. In rare situations, death has been associated with some of the adverse reactions listed above. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reporlanimalae

NDC No. 86101-032-42 Carprofen Sterile Injectable Solution 50 mg/mL

During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies of osteoarthritis with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Osteoarthritis Field Study (2 mg/lb once daily) Observation Carprofen Tablets (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 — SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the tablet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Tablets (2 mg/lb once daily) Observation* Carprofen Tablets (n=148) Placebo (n=149) Vomiting 10.1 13.4 Diarrhea/Soft stool 6.1 6.0 Ocular disease 2.7 0 Inappetence 1.4 0 Dermatitis/Skin lesion 2.0 1.3 Dysrhythmia 0.7 0 Apnea 1.4 0 Oral/Periodontal disease 1.4 0 Pyrexia 0.7 1.3 Urinary tract disease 1.4 1.3 Wound drainage 1.4 0 *A single dog may have experienced more than one occurrence of an event. Post-Approval Experience: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system. Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis. Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers. Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation. Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria. Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness. Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis. Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis. Immunologic or hypersensitivity: Facial swelling, hives, erythema. In rare situations, death has been associated with some of the adverse reactions listed above. CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Jvet Pharmaceuticals, LLC at 1-727-292-1166. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Vetprofen® (Carprofen Flavored Tablets) Non-steroidal anti-inflammatory drug For oral use in dogs only

During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for Carprofen- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies of osteoarthritis with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the tablet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control. Post-Approval Experience: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system. Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis. Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers. Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation. Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria. Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness. Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis. Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis. Immunologic or hypersensitivity: Facial swelling, hives, erythema. In rare situations, death has been associated with some of the adverse reactions listed above. CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) call 1-727-292-1166. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Novox®(Carprofen flavored tablets) For oral use in dogs only Non-Steroidal Anti-inflammatory Drug

During investigational studies for the caplet formulation with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily) Observation Rimadyl (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 — SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily) ObservationA single dog may have experienced more than one occurrence of an event. Rimadyl (n=148) Placebo (n=149) Vomiting 10.1 13.4 Diarrhea/Soft stool 6.1 6.0 Ocular disease 2.7 0 Inappetence 1.4 0 Dermatitis/Skin lesion 2.0 1.3 Dysrhythmia 0.7 0 Apnea 1.4 0 Oral/Periodontal disease 1.4 0 Pyrexia 0.7 1.3 Urinary tract disease 1.4 1.3 Wound drainage 1.4 0 * A single dog may have experienced more than one occurrence of an event. During investigational studies for the chewable tablet formulation, gastrointestinal signs were observed in some dogs. These signs included vomiting and soft stools.

RIMADYL® (carprofen)

ADVERSE REACTIONS: During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control. There were no serious adverse events reported during clinical field studies of osteoarthritis with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Osteoarthritis Field Study (2 mg/lb once daily) Observation Carprofen tablets (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 -- SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the tablet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Tablets (2 mg/lb once daily) ObservationA single dog may have experienced more than one occurrence of an event. Carprofen tablets (n=148) Placebo (n=149) Vomiting 10.1 13.4 Diarrhea/soft stool 6.1 6.0 Ocular disease 2.7 0 Inappetence 1.4 0 Dermatitis/skin lesion 2.0 1.3 Dysrhythmia 0.7 0 Apnea 1.4 0 Oral/periodontal disease 1.4 0 Pyrexia 0.7 1.3 Urinary tract disease 1.4 1.3 Wound drainage 1.4 0

Flexprofen® (carprofen) Tablets

During investigational studies for the caplet formulation, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control.There were no serious adverse events reported during clinical field studies with once daily oral administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily) Observation Rimadyl (n=129) Placebo (n=132) Inappetence 1.6 1.5 Vomiting 3.1 3.8 Diarrhea/Soft stool 3.1 4.5 Behavior change 0.8 0.8 Dermatitis 0.8 0.8 PU/PD 0.8 — SAP increase 7.8 8.3 ALT increase 5.4 4.5 AST increase 2.3 0.8 BUN increase 3.1 1.5 Bilirubinuria 16.3 12.1 Ketonuria 14.7 9.1 Clinical pathology parameters listed represent reports of increases from pre-treatment values; the use of clinical judgement is necessary to determine clinical relevance (refers also to table below). There were no serious adverse events reported during clinical field studies for the injectable formulation. The following categories of abnormal health observations were reported. Saline served as placebo control. Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Studies with the Injectable ObservationA single dog may have experienced more than one occurrence of an event. Rimadyl (n=168) Placebo (n=163) Vomiting 10.1 9.2 Diarrhea/soft stool 2.4 3.7 Dermatitis 0.6 1.2 Dysrhythmia 0.6 0.6 Swelling 0 1.2 Dehiscence 1.2 0 WBC increase 13.7 6.7 * A single dog may have experienced more than one occurrence of an event.

RIMADYL®

The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

Oral

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Carprieve® Chewable Tablets

The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

Subcutaneous

Carofenvet™

The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.

Oral

CARPROFEN Soft Chewable Tablets

2 milligram per pound (4.4 milligrams per kilogram) body weight once daily or 1 milligram per pound (2.2 milligrams per kilogram) body weight twice daily, by subcutaneous injection.

Subcutaneous

For use in dogs only. Do not use in cats. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For the control of postoperative pain, administer approximately 2 hours before the procedure.

Rimadyl® Sterile Injectable Solution

2 mg/lb. (4.4 mg/kg) body weight once daily or 1 mg/lb. pound (2.2 mg/kg) body weight twice daily.

Subcutaneous

For use in dogs only. Do not use in cats. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For the control of postoperative pain, administer approximately 2 hours before the procedure.

Carprofen Injection

2 milligram per pound (4.4 mg/kg) of body weight once daily or 1 milligram per pound twice daily.

Oral

For use in dogs only. Not for use in cats. For the control of postoperative pain, administer approximately 2 hours before the procedure. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Rimadyl® Caplets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprofen Chewable Tablets and other treatment options before deciding to use Carprofen Chewable Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Carprofen Chewable Tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Carprofen Chewable Tablets may be fed by hand or placed in food. Care should be taken to ensure that the dog consumes the complete dose. Half-tablets should be used within 90 days. EFFECTIVENESS: Confirmation of the effectiveness of carprofen for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries, was demonstrated in 5 placebo-controlled, masked studies examining the anti-inflammatory and analgesic effectiveness of carprofen caplets in various breeds of dogs. Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic effectiveness of carprofen caplets when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these 2 field studies, dogs diagnosed with osteoarthritis showed statistically significant overall improvement based on lameness evaluations by the veterinarian and owner observations when administered carprofen at labeled doses. Separate placebo-controlled, masked, multicenter field studies confirmed the effectiveness of carprofen caplets for the control of postoperative pain when dosed at 2 mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy, cruciate repair and aural surgeries were administered carprofen preoperatively and for a maximum of 3 days (soft tissue) or 4 days (orthopedic) postoperatively. In general, dogs administered carprofen showed statistically significant reduction in pain scores compared to controls. ANIMAL SAFETY: Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that carprofen is well tolerated in dogs after oral administration. In target animal safety studies, carprofen was administered orally to healthy Beagle dogs at 1, 3, and 5 mg/lb twice daily (1, 3 and 5 times the recommended total daily dose) for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female dog receiving 5 mg/lb twice daily decreased to 2.1 g/dl after 2 weeks of treatment, returned to the pre-treatment value (2.6 g/dL) after 4 weeks of treatment, and was 2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated with 1 mg/lb twice daily and in 1 dog (2 incidents) treated with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that received 3 mg/lb twice daily. Two of 8 dogs receiving 10 mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia. The mean albumin level in the dogs receiving this dose was lower (2.38 g/dL) than each of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three incidents of black or bloody stool were observed in 1 dog. Five of 8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic examination. Histologic examination of these areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of the 5 dogs. In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to 11.4 mg/lb/day (5.7 times the recommended total daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the animals. No gross or histologic changes were seen in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine aminotransferase (ALT) of approximately 20 IU. In the 52-week study, minor dermatologic changes occurred in dogs in each of the treatment groups but not in the control dogs. The changes were described as slight redness or rash and were diagnosed as non-specific dermatitis. The possibility exists that these mild lesions were treatment related, but no dose relationship was observed. Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses for 14 days (297 dogs were included in a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb once daily). In both studies the drug was clinically well tolerated and the incidence of clinical adverse reactions for carprofen-treated animals was no higher than placebo-treated animals (placebo contained inactive ingredients found in carprofen). For animals receiving 1 mg/lb twice daily, the mean post-treatment serum ALT values were 11 IU greater and 9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. Differences were not statistically significant. For animals receiving 2 mg/lb once daily, the mean post-treatment serum ALT values were 4.5 IU greater and 0.9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. In the latter study, 3 carprofen-treated dogs developed a 3-fold or greater increase in (ALT) and/or (AST) during the course of therapy. One placebo-treated dog had a greater than 2-fold increase in ALT. None of these animals showed clinical signs associated with laboratory value changes. Changes in clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant. The 1 mg/lb twice daily course of therapy was repeated as needed at 2-week intervals in 244 dogs, some for as long as 5 years. Clinical field studies were conducted in 297 dogs of different breeds undergoing orthopedic or soft tissue surgery. Dogs were administered 2 mg/lb of carprofen two hours prior to surgery then once daily, as needed for 2 days (soft tissue surgery) or 3 days (orthopedic surgery). Carprofen was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health observation in carprofen- and placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation was vomiting and was observed at approximately the same frequency in carprofen- and placebo-treated animals. Changes in clinicopathologic indices of hematopoietic, renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT values were 7.3 IU and 2.5 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. The mean post-treatment AST values were 3.1 IU less for dogs receiving carprofen and 0.2 IU greater for dogs receiving placebo.

ORAL

Carprofen Chewable Tablets (carprofen) Non-steroidal anti-inflammatory drug For oral use in dogs only

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprieve and other treatment options before deciding to use Carprieve. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Carprieve chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. These liver flavored Carprieve chewable tablets may be offered to the dog by hand or placed on food. If the dog does not willingly consume the tablets, they may be hand-administered (pilled) as with other oral tablet medications. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

FDA application 200-595

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of OstiFen and other treatment options before deciding to use OstiFen. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. OstiFen chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. These liver flavored OstiFen chewable tablets may be offered to the dog by hand or placed on food. If the dog does not willingly consume the tablets, they may be hand-administered (pilled) as with other oral tablet medications. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

FDA application 200-595

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Rimadyl and other treatment options before deciding to use Rimadyl. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Rimadyl chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Rimadyl chewable tablets are palatable and willingly consumed by most dogs when offered by the owner. Therefore, they may be fed by hand or placed on food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

RIMADYL® (carprofen)

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Rovera and other treatment options before deciding to use Rovera. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Rovera chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Rovera chewable tablets are palatable and willingly consumed by most dogs when offered by the owner. Therefore, they may be fed by hand or placed on food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

Rovera® (carprofen) Chewable Tablets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of MOVODYL Chewable Tablets and other treatment options before deciding to use MOVODYL Chewable Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. MOVODYL Chewable Tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. MOVODYL Chewable Tablets may be fed by hand or placed in food. Care should be taken to ensure that the dog consumes the complete dose. Half- tablets should be used within 90 days.

ORAL

MOVODYLTM Chewable Tablets (carprofen)

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprovet and other treatment options before deciding to use Carprovet. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb (4.4 mg/kg) of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Carprovet chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Carprovet chewable tablets may be fed by hand or placed on food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

Carprovet® (carprofen) Chewable Tablets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprofen Soft Chewable Tablets and other treatment options before deciding to use Carprofen Soft Chewable Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Carprofen Soft Chewable Tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Carprofen Soft Chewable Tablets may be fed by hand or placed in food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

CARPROFEN Soft Chewable Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Novox and other treatment options before deciding to use Novox. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb (4.4 mg/kg) of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Novox chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Novox chewable tablets may be fed by hand or placed on food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

Novox® (carprofen) Chewable Tablets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Levafen Chewable Tablets and other treatment options before deciding to use Levafen Chewable Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Levafen Chewable Tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Levafen Chewable Tablets may be fed by hand or placed in food. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

LEVAFENTM (carprofen) Chewable Tablets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of quellin and other treatment options before deciding to use quellin. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. quellin soft chewable tablets are scored and dosage should be calculated in half-tablet increments. Soft chewable tablets can be halved by holding the tablet on each side of the score line and pressing up in the middle to break the tablet into two pieces. Care should be taken to ensure that the dog consumes the complete dose.

ORAL

quellin

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Flexprofen Tablets and other treatment options before deciding to use Flexprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Flexprofen® (carprofen) Tablets

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Flexprofen Tablets and other treatment options before deciding to use Flexprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

Flexprofen® (carprofen) TabletsCapletsNon-steroidal anti-inflammatory drug

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Levafen™ (carprofen) Tablets and other treatment options before deciding to use Levafen™ (carprofen) Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Levafen™ (carprofen) Tablets Flavored Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprovet and other treatment options before deciding to use Carprovet. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Carprovet® (carprofen tablets) Flavored Tablets

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprovet and other treatment options before deciding to use Carprovet. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

Carprovet® (carprofen tablets) Caplets

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Novox and other treatment options before deciding to use Novox. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

Novox® (carprofen tablets) Caplets

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprofen Tablets and other treatment options before deciding to use Carprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Approved by FDA under ANADA # 200-767 Carprofen Tablets Flavored Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carprofen Tablets and other treatment options before deciding to use Carprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

Carprofen Tablets Caplets Non-steroidal anti-inflammatory drug For oral use in dogs only

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of OstiFen Tablets and other treatment options before deciding to use OstiFen Tablets. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

OstiFen™ (carprofen) Tablets Flavored Tablets Non-steroidal anti-inflammatory drug For oral use in dogs only

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Vetprofen and other treatment options before deciding to use Vetprofen. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Vetprofen® (Carprofen Flavored Tablets) Non-steroidal anti-inflammatory drug For oral use in dogs only

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of CARPRIEVE and other treatment options before deciding to use CARPRIEVE. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

FDA application 200-498

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Rimadyl and other treatment options before deciding to use Rimadyl. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Caplets are scored and dosage should be calculated in half-caplet increments.

ORAL

RIMADYL® (carprofen)

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Novox and other treatment options before deciding to use Novox. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments.

ORAL

Novox®(Carprofen flavored tablets) For oral use in dogs only Non-Steroidal Anti-inflammatory Drug

DOSAGE AND ADMINISTRATION: Carefully consider the potential benefits and risks of Carprovet and other treatment options before deciding to use Carprovet. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

Carprovet® (carprofen)Sterile Injectable Solution50 mg/mL

Carefully consider the potential benefits and risks of Flexprofen® (carprofen) Injectable and other treatment options before deciding to use Flexprofen. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

Flexprofen® (carprofen) Sterile Injectable Solution 50 mg/mL

The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure. <span style="font-size: 10pt; font-family: 'Verdana','sans-serif'; line-height: 115%; mso-fareast-font-family: Calibri; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA

Subcutaneous

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Carprieve® Injection

Carefully consider the potential benefits and risks of carprofen and other treatment options before deciding to use Carprieve Injection. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

FDA application 200-520

Carefully consider the potential benefits and risks of OstiFen® and other treatment options before deciding to use OstiFen®. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

VEToneOstiFen®(carprofen)Sterile Injectable Solution - 50 mg/mLNon-steroidal anti-inflammatory drugFor subcutaneous use in dogs only

Carefully consider the potential benefits and risks of Rimadyl and other treatment options before deciding to use Rimadyl. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

RIMADYL®

Carefully consider the potential benefits and risks of Levafen and other treatment options before deciding to use Levafen. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

SUBCUTANEOUS

LevafenTM (carprofen)Sterile Injectable Solution 50 mg/mLNon-steroidal anti-inflammatory drugFor subcutaneous use in dogs only

The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2. mg/kg) twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Tablets are scored and dosage should be calculated in half-tablet increments

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian

Carprofen Flavored Tablets

The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative pain, administer approximately 2 hours before the procedure.

Subcutaneous

Carprofen Sterile Injectable Solution

2 mg per pound (lb) of body weight once daily or 1 mg/lb twice daily for the control of postoperative pain; administer approximately 2 hours before procedure

Oral

Federal Law restricts this drug to use by or on the order of a licensed veterinarian

quellin®