Ranitidine 300 MG Oral Capsule
INDICATIONS AND USAGE Ranitidine hydrochloride is indicated in: 1. 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. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year. 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. 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. 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year. 6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily. 8. 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.
Sandoz Inc
CAPSULE BROWN GG 615
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HOW SUPPLIED
RANITIDINE HYDROCHLORIDE capsules, for oral administration, are available as: 150 mg: Opaque caramel capsules, imprinted GG 614 in white ink, filled with off-white powder and supplied as: NDC 0781-2855-60 bottles of 60 capsules NDC 0781-2855-05 bottles of 500 capsules 300 mg: Opaque caramel capsules, imprinted GG 615 in white ink, filled with off-white powder and supplied as: NDC 0781-2865-31 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Protect from light. Replace cap securely after each opening. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. KEEP OUT OF THE REACH OF CHILDREN. The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
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