ranitidine 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 Tablets, USP 150 mg b.i.d. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets, USP 150 mg q.i.d. 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.
amneal pharmaceuticals of new york, llc
ROUND ORANGE IP 253
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HOW SUPPLIED
RANITIDINE Tablets, USP 150 mg (
RANITIDINE HCl equivalent to 150 mg of
RANITIDINE) are supplied as orange, round, biconvex aqueous film-coated tablets debossed “IP 253” on one side and plain on the reverse. They are available as follows: Bottles of 60: NDC 53746-253-60 Bottles of 100: NDC 53746-253-01 Bottles of 180: NDC 53746-253-18 Bottles of 500: NDC 53746-253-05 Bottles of 1000: NDC 53746-253-10
RANITIDINE Tablets, USP 300 mg (
RANITIDINE HCl equivalent to 300 mg of
RANITIDINE) are supplied as yellow, capsule-shaped aqueous film-coated tablets debossed “IP 254” on one side and plain on the reverse. They are available as follows: Bottles of 30: NDC 53746-254-30 Bottles of 100: NDC 53746-254-01 Bottles of 250: NDC 53746-254-02 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP. Protect from light. Replace cap securely after each opening. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 09-2015-02
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