metoclopramide 10 mg
1 INDICATIONS AND USAGE Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use: Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 )
par pharmaceutical, inc.
ROUND WHITE R 269
R 269 ROUND WHITE
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16 HOW SUPPLIED 10 mg - Each white, round tablet imprinted with “p” on one side and 685 and bisect on the other side contains 10 mg of metoclopramide (as the hydrochloride). Tablets are supplied in bottles of 100 (NDC 49884-689-01) and 500 (NDC 49884-689-05). Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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