Ranitidine 150 MG Oral Tablet
INDICATIONS AND USAGE Ranitidine Tablets USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
IVAX Pharmaceuticals, Inc.
ROUND BROWN 4357 150
4357 150 ROUND BROWN
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HOW SUPPLIED Ranitidine Tablets USP, 150 mg are available as beige, unscored, round, film-coated tablets debossed 4357” on one side and “150” on the other side containing 150 mg ranitidine as ranitidine hydrochloride packaged in bottles of 60 and 500 tablets. Ranitidine Tablets USP, 300 mg are available as beige, unscored, oval, film-coated tablets debossed 4358” on one side and “300” on the other side containing 300 mg ranitidine as ranitidine hydrochloride packaged in bottles of 30, and 100 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) in a dry place [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Replace cap securely after each opening. Rev. B 10/2009 Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 RANITIDINE TABLETS USP Company logo Company logo
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