amphetamine sulfate amphetamine tablet
INDICATIONS AND USAGE Amphetamine sulfate tablets, USP 5 mg and 10 mg are indicated for: 1. Narcolepsy 2. Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. 3. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.
amneal pharmaceuticals ny llc
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HOW SUPPLIED
AMPHETAMINE Sulfate Tablets USP, 5 mg are supplied as white, round biconvex tablets, plain on one side, and ‘5’ with score on the other side. They are available as follows: Bottles of 100: NDC 69238-1563-1
AMPHETAMINE Sulfate Tablets USP, 10 mg are supplied as blue, round biconvex tablets, plain on one side, and ‘10’ with double scores on the other side. They are available as follows: Bottles of 100: NDC 69238-1564-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP. Manufactured by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Rev. 10-2023-06 Dispense with Medication Guide available at: documents.amneal.com/mg/
AMPHETAMINE-tab.pdf
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