ranitidine ranitidine tablet film coated
INDICATIONS AND USAGE Ranitidine tablets are 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 eight weeks. 2. 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. 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 studies have been carried out for 1 year. 6. Treatment of GERD: Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg b.i.d. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg q.i.d. 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.
GENPHARM, L.P.
ROUND WHITE G 00 30
G 00 30 ROUND WHITE
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ranitidine ranitidine tablet film coated
genpharm, l.p.
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HOW SUPPLIED Ranitidine Tablets USP, 150 mg and 300 mg for oral administration are available as: 150 mg tablets - white to off-white, round, biconvex, film-coated tablets with “G” on one side and “00” over “30” on the other side. Bottles of 60- NDC # 55530-030-06 Bottles of 100- NDC # 55530-030-35 Bottles of 500- NDC # 55530-030-05 Bottles of 1000- NDC # 55530-030-10 300 mg tablets - white to off-white, capsule shaped, film-coated tablets with “G” on one side and “0031” on the other side. Bottles of 30- NDC # 55530-031-03 Bottles of 100- NDC # 55530-031-01 Bottles of 250- NDC # 55530-031-25 Store at controlled room temperature between 15°C and 30°C (59°F and 86°F) in a dry place. Protect from light. Replace cap securely after each opening. Dispense in a tight, light-resistant container as defined in the USP. Rx only. Manufactured for: GENPHARM, L.P. NAPA, CA 94558 Manufactured by: GENPHARM INC. Toronto, Ontario Canada M8Z 2S6
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