Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Rebel Distributors Corp
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, bu
are supplied as white, capsule-shaped, scored tablets, debossed "3592" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 8, 10, 12, 15, 20, 21, 24, 30, 40, 45, 60 and 90. are supplied as pink, capsule-shaped tablets, debossed "3600" on one side and debossed "V" on the reverse side. The tablets are supplied in containers of 8, 10, 20, 30, 60 and 90. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. A Schedule CIII Narcotic.
Abbreviated New Drug Application
HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET REBEL DISTRIBUTORS CORP ---------- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII RX ONLY BOXED WARNING HEPATOTOXICITY: ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT. DESCRIPTION Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17- methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 2.5 MG/500 MG Each tablet contains: Hydrocodone Bitartrate ............. 2.5 mg Acetaminophen ......................... 500 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red #3, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sucrose. May also contain crospovidone. Meets USP Dissolution Test 1. HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG Each tablet contains: Hydrocodone Bitartrate ................. 5 mg Acetaminophen ............................. 325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and sugar spher সম্পূর্ণ নথি পড়ুন