reprexain hydrocodone bitartrate and ibuprofen tablet film coated
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of REPREXAIN™ and other treatment options before deciding to use REPREXAIN™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). REPREXAIN™ tablets are indicated for the short-term (generally less than 10 days) management of acute pain. REPREXAIN™ is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.
quinnova pharmaceuticals, llc
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HOW SUPPLIED REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets), 2.5 mg/200 mg, are supplied as white, capsule-shaped, film-coated tablets, debossed “IP 116” on obverse and plain on reverse. They are available as follows: Bottles of 100 NDC 23710-900-01 REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets), 5 mg/200 mg, are supplied as white, oval-shaped, film-coated tablets, debossed “IP 146” on obverse and plain on reverse. They are available as follows: Bottles of 100 NDC 23710-901-01 REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets), 10 mg/200 mg, are supplied as yellow, round-shaped, film-coated tablets, debossed “IP 117” on obverse and plain on reverse. They are available as follows: Bottles of 100 NDC 23710-902-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance.
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