Famotidine 20 MG Oral Tablet
INDICATIONS AND USAGE Famotidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. 3. Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. 4. Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ). 5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS , Clinical Studies ) .
Alembic Pharmaceuticals Limited
ROUND YELLOW L113 20
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HOW SUPPLIED
FAMOTIDINE Tablets, USP, 20 mg, are yellow colored, circular, biconvex film-coated tablets embossed with 'L113'on one side and '20' on the other side. NDC 46708-293-30 bottles of 30 NDC 46708-293-31 bottles of 100 NDC 46708-293-71 bottles of 500 NDC 46708-293-91 bottles of 1000 NDC 46708-293-10 Unit dose tablets of 100 (10 x 10)
FAMOTIDINE Tablets, USP, 40 mg, are brown colored, circular, biconvex film-coated tablets embossed with 'L114'on one side and '40' on the other side. NDC 46708-294-30 bottles of 30 NDC 46708-294-31 bottles of 100 NDC 46708-294-71 bottles of 500 NDC 46708-294-91 bottles of 1000 NDC 46708-294-10 Unit dose tablets of 100 (10 x 10) Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal 389350, Gujarat, India. Revised: 10/2015
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