Ranitidine 300 MG Oral Tablet
INDICATIONS AND USAGE Ranitidine tablets, USP is indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials 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. Trials 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 trials 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.
strides pharma science limited
ROUND BROWN S 430
S 430 ROUND BROWN
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HOW SUPPLIED Ranitidine tablets, USP 150 mg (ranitidine HCI USP equivalent to 150 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/429" on one side and plain on the other side. They are available in bottles of 60 (NDC 64380-803-03, 64380-936-03 ), 100 (NDC 64380-803-06, 64380-936-06), 500 (NDC 64380-803-07, 64380-936-07) and 1000 (NDC 64380-803-08, 64380-936-08) tablets. Ranitidine tablets, USP 300 mg (ranitidine HCI USP equivalent to 300 mg of ranitidine) are brown coloured, circular shaped, biconvex, beveled edge film-coated tablets debossed with "S/430" on one side and plain on the other side. They are available in bottles of 30 (NDC 64380-804-04, 64380-937-04), 100 (NDC 64380-804-06, 64380-937-06) and 250 (NDC 64380-804-38, 64380-937-38) tablets. Store at 20° to 25° C (68° and 77°F); excursions permitted between 15° and 30° C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 06/ 2019
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