Naltrexone hydrochloride 50 MG Oral Tablet

INDICATIONS AND USAGE Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

Accord Healthcare, Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] off label use` `[4] diarrhoea` `[5] nausea` `[6] pneumonia` `[7] pyrexia` `[8] death` `[9] dyspnoea` `[10] rash`

5 years ago

OVAL YELLOW 50

5 years ago

50 OVAL YELLOW

HOW SUPPLIED

NALTREXONE HYDROCHLORIDE tablets USP 50 mg yellow coloured, oval, biconvex, film-coated tablets with breakline on one side and '50' debossed on the other side. Available in bottles of: 30 Tablets with a child-resistant closure NDC 16729-081-10 100 Tablets with a child-resistant closure NDC 16729-081-01 500 Tablets NDC 16729-081-16 1000 Tablets NDC 16729-081-17 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container. For more information, go to www.accordhealthcare.us or call Accord Healthcare at 1-866-941-7875. Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 6947 0 6025148 Issued October 2023

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