... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR520.1468] [Page 190] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS -Table of Contents Sec. 520.1468 Naproxen granules. (a) Specifications. Naproxen granules contain 50 percent naproxen. (b) Sponsor. No. 000856 in Sec. 510.600 (c) of this chapter. (c) Conditions of use (1) Horses. The drug is used for the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse. (2 )( i) For oral maintenance therapy following initial intravenous dosage, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as top dressing in the animal's feed for up to 14 consecutive days. The initial intravenous dosage ...

... damage or gastrointestinal bleeding). OTC drug products containing internal analgesic / antipyretic active ingredients may cause similar adverse effects. FDA concludes that the labeling of OTC drug products containing internal analgesic / antipyretic active ingredients should advise consumers with a history of heavy alcohol use to consult a physician. Accordingly, any OTC drug product, labeled for adult use, containing any internal analgesic / antipyretic active ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate) alone or in combination shall bear an alcohol warning statement in its labeling as follows: (1) Acetaminophen. `` Alcohol Warning ' [heading in boldface type ]: `` If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers / fever reducers. Acetaminophen may cause liver damage ' (2) Nonsteroidal anti-inflammatory analgesic / antipyretic active ingredients -including but not limited to aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, ...

... [Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1, 2009] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR522.1468] [Page 290-291] TITLE 21 -FOOD AND DRUGS CHAPTER I -FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 522_IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS -Table of Contents Sec. 522.1468 Naproxen for injection. (a) Specifications. The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter). (b) Sponsor. See 000856 in Sec. 510.600 (c) of this chapter. (c) Conditions of use in horses (1) Dosage. Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days. (2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well ...

... do not fit within one of the categories listed in paragraphs (c )( 5 )( i) through (c )( 5 )( vii ), (c )( 5 )( ix ), and (c )( 5 )( x) of this section. (ix) The pregnancy / breast-feeding warning set forth in Sec. 201.63 (a ); the third trimester warning set forth in Sec. 201.63 (e) for products containing aspirin or carbaspirin calcium; the third trimester warning set forth in approved drug applications for products containing ketoprofen, naproxen sodium, and ibuprofen (not intended exclusively for use in children). (x) The `` Keep out of reach of children ' warning and the accidental overdose / ingestion warning set forth in Sec. 330.1 (g) of this chapter. (6) `` Directions, followed by the directions for use described in an applicable OTC drug monograph or approved drug application. [[ Page 48 ]] (7) `` Other information, followed by additional information that is not included under paragraphs (c )( 2) through (c )( ...

... dosage forms. 522.1222a Ketamine. 522.1222b Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection. 522.1225 Ketoprofen solution. 522.1244 Levamisole phosphate injection. 522.1260 Lincomycin. 522.1289 Lufenuron suspension. 522.1290 Luprostiol sterile solution. 522.1315 Maropitant. 522.1335 Medetomidine hydrochloride injection. 522.1350 Melatonin implant. 522.1362 Melarsomine dihydrochloride for injection. 522.1367 Meloxicam. 522.1372 Mepivacaine. 522.1380 Methocarbamol injection. 522.1410 Sterile methylprednisolone acetate suspension. 522.1450 Moxidectin solution. 522.1451 Moxidectin for suspension. 522.1452 Nalorphine hydrochloride injection. 522.1462 Naloxone hydrochloride injection. 522.1465 Naltrexone hydrochloride injection. 522.1468 Naproxen for injection. 522.1484 Neomycin sulfate sterile solution. 522.1503 Neostigmine methylsulfate injection. 522.1610 Oleate sodium solution. 522.1620 Orgotein for injection. 522.1642 Oxymorphone hydrochloride injection. 522.1660 Oxytetracycline injectable dosage forms. 522.1660a Oxytetracycline solution, 200 milligrams / milliliter. 522.1660b Oxytetracycline solution, 300 milligrams / milliliter. 522.1662 Oxytetracycline hydrochloride implantation or injectable dosage forms. 522.1662a Oxytetracycline hydrochloride injection. 522.1662b Oxytetracycline hydrochloride with lidocaine injection. 522.1680 Oxytocin injection. 522.1696 Penicillin G procaine implantation and injectable dosage forms. 522.1696a Penicillin G benzathine and penicillin G procaine suspension. 522.1696b Penicillin G ...

... tablets. 520.1350 Meloxicam. 520.1380 Methocarbamol tablets. 520.1390 (S )-methoprene. 520.1408 Methylprednisolone tablets. 520.1409 Methylprednisolone, aspirin tablets. 520.1422 Metoserpate hydrochloride. 520.1430 Mibolerone. 520.1445 Milbemycin oxime tablets. 520.1446 Milbemcyin oxime and lufenuron tablets. 520.1448 Monensin oral dosage forms. 520.1448a Monensin blocks. 520.1450 Morantel tartrate oral dosage forms. 520.1450a Morantel tartrate bolus. 520.1450b Morantel tartrate cartridge. 520.1450c Morantel tartrate sustained-release trilaminate cylinder / sheet. 520.1451 Moxidectin tablets. 520.1452 Moxidectin gel. 520.1453 Moxidectin and praziquantel gel. 520.1454 Moxidectin solution. 520.1468 Naproxen granules. 520.1484 Neomycin. 520.1498 Nitazoxanide paste. 520.1510 Nitenpyram tablets. 520.1615 Omeprazole. 520.1616 Orbifloxacin. 520.1628 Oxfendazole powder and pellets. 520.1629 Oxfendazole paste. 520.1630 Oxfendazole suspension. 520.1631 Oxfendazole and trichlorfon paste. 520.1638 Oxibendazole paste. 520.1640 Oxibendazole suspension. 520.1660 Oxytetracycline. 520.1660a Oxytetracycline and carbomycin in combination. 520.1660b Oxytetracycline hydrochloride capsules. 520.1660c Oxytetracycline hydrochloride tablets / boluses. 520.1660d Oxytetracycline powder. 520.1696 Penicillin oral dosage forms. 520.1696a Buffered penicillin powder, penicillin powder with buffered aqueous diluent. 520.1696b Penicillin G potassium in drinking water. 520.1696c Penicillin ...