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NDC 62559-0190-16

Metoclopramide 5 mg/5mL SOLUTION

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NDC
62559-0190-16
Generic Name
Metoclopramide
Brand Name
Metoclopramide
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Package Size
Labeler
ANI Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of post-prandial and daytime heartburn with less observed effect on nocturnal s…

Important Warnings

WARNINGS Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. Extrapyramidal symptoms, manifested primarily as acute dystonic reactions,…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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