famotidine 40 mg
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer. • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of DU recurrence.
Camber Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
FAMOTIDINE Tablets USP, 20 mg, are light yellow, round, biconvex, film-coated tablets debossed with “T” on one side and “11” on the other side. They are supplied as follows: Bottles of 100 NDC 31722-017-01 Bottles of 1000 NDC 31722-017-10
FAMOTIDINE Tablets USP, 40 mg, are white, round, biconvex, film-coated tablets debossed with “T” on one side and “12” on the other side. They are supplied as follows: Bottles of 100 NDC 31722-018-01 Bottles of 500 NDC 31722-018-05 Bottles of 1000 NDC 31722-018-10 Storage 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]. Dispense in a USP tight, light-resistant container.
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