Reprexain hydrocodone bitartrate 10 MG ibuprofen 200 MG Oral Tablet
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.
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ROUND YELLOW IP 117
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HOW SUPPLIED REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) are available as: 2.5 mg/200 mg: white capsule shaped, film coated tablets, debossed “IP 116” on obverse and plain on reverse. Bottles of 100: NDC 63717-900-01 Sample boxes of 10 tablets: NDC 63717-900-99 5 mg/200 mg: white, oval shaped, film coated tablets, debossed “IP 146” on obverse and plain on reverse. Bottles of 100: NDC 63717-901-01 Sample boxes of 10 tablets: NDC 63717-901-99 10 mg/200 mg: yellow, round shaped, film coated tablets, debossed “IP 117” on obverse and plain on reverse. Bottles of 100: NDC 63717-902-01 Sample boxes of 10 tablets: NDC 63717-902-99 Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-III Controlled Substance. Manufactured For: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 Rev. 12/08 HI251 NDC 63717-900-01 Reprexain™ CIII (hydrocodone bitartrate and ibuprofen tablet) 2.5 mg/200 mg Rx only 100 Tablets Hawthorn Pharmaceuticals, Inc. Each tablet contains: Hydrocodone bitartrate USP, 2.5 mg Ibuprofen USP, 200 mg Usual Dosage: See package insert. Dispense in light resistant container as defined in the USP. Store at 25 o C (77 o F); excursions permitted to controlled room temperature 15 o -30 o C (59 o -86 o F). Mfd. for: Hawthorn Pharmaceuticals, Inc. Madison, Ms 39110 HI200 11/05
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