Dextroamphetamine Saccharate Amphetamine Aspartate Dextroamphetamine Sulfate and Amphetamine Sulfate Amphetamine aspartate 7.5 MG Amphetamine Sulfate 7.5 MG Dextroamphetamine saccharate 7.5 MG Dextroamphetamine Sulfate 7.5 MG Oral Tablet
INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Barr Laboratories Inc.
OVAL ORANGE B 974 3 0
B 974 3 0 OVAL ORANGE
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dextroamphetamine saccharate amphetamine aspartate dextroamphetamine sulfate and amphetamine sulfate tablet
teva pharmaceuticals usa, inc.
dextroamphetamine saccharate amphetamine aspartate dextroamphetamine sulfate and amphetamine sulfate tablet
teva pharmaceuticals usa, inc.
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HOW SUPPLIED
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablets (Mixed salts of a single entity amphetamine product) are supplied as follows: 5 mg: blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 971 and four partial bisects on the other side debossed with 5. They are available in bottles of 100 tablets (NDC 0555-0971-02). 7.5 mg: blue, round, flat-faced, beveled-edge tablet debossed with stylized b over 775 on one side and two partial bisects and a full score on the other side debossed with 7 | 1/2. They are available in bottles of 100 tablets (NDC 0555-0775-02). 10 mg: blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 972 and two partial bisects and a full score on the other side debossed with 1 | 0. They are available in bottles of 100 tablets (NDC 0555-0972-02). 12.5 mg: peach, oval, biconvex tablet debossed with stylized b over 776 separated by a full score on one side and four partial bisects on the other side debossed with 12 1/2. They are available in bottles of 100 tablets (NDC 0555-0776-02). 15 mg: peach, round, flat-faced, beveled-edge tablet debossed with stylized b over 777 on one side and two partial bisects and a full score on the other side debossed with 1 | 5. They are available in bottles of 100 tablets (NDC 0555-0777-02). 20 mg: peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 973 and two partial bisects and a full score on the other side debossed with 2 | 0. They are available in bottles of 100 tablets (NDC 0555-0973-02). 30 mg: peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 974 and two partial bisects and a full score on the other side debossed with 3 | 0. They are available in bottles of 100 tablets (NDC 0555-0974-02). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are trademarks of their respective owners. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. M 9/2023
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