cimetidine 800 mg
INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD ). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
aurobindo pharma limited
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HOW SUPPLIED
CIMETIDINE Tablets, USP are available containing 200 mg, 300 mg, 400 mg or 800 mg of
CIMETIDINE, USP. The 200 mg tablets are green colored, film-coated oval shaped tablets, debossed with C 2 on one side and plain on other side. They are available as follows: Bottles of 100 NDC 59651-823-01 The 300 mg tablets are green colored, film-coated round tablets, debossed with C 3 on one side and plain on other side. They are available as follows: Bottles of 100 NDC 59651-824-01 The 400 mg tablets are green colored, film-coated oval shaped tablets, debossed with C and 4 separated by score line on one side and score line on other side. They are available as follows: Bottles of 100 NDC 59651-825-01 Bottles of 500 NDC 59651-825-05 The 800 mg tablets are green colored, film-coated oval shaped tablets, debossed with C and 8 separated by score line on one side and score line on other side. They are available as follows: Bottles of 100 NDC 59651-826-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Issued: January 2024
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