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Label Changes for:

Strattera (atomoxetine hydrochloride) Capsules

April 2015

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

Adderall (mixed salts of a single-entity amphetamine product) Tablets
Adderall XR (dextroamphetamine mixed salts of a single entity amphetamine product) Capsules
Concerta (methylphenidate HCl) Extended-release Tablets
Daytrana (methylphenidate transdermal system)
Desoxyn (methamphetamine hydrochloride) Tablets
Dexedrine (dextroamphetamine sulfate) Spansule Sustained Release Capsules
Focalin (dexmethylphenidate HCl) tablets
Focalin XR (dexmethylphenidate HCl) Extended-release Tablets
Metadate CD (methylphenidate HCl) Extended-Release Capsules
Methylin (methylphenidate) Chewable Tablets
Methylin (methylphenidate) Oral Solution
Quillivant XR (methylphenidate hydrochloride) Extended-release Oral Suspension
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets 
Strattera (atomoxetine hydrochloride) Capsules
Vyvanse (lisdexamfetamine dimesylate) Capsules

April 2015

ADVERSE REACTIONS

  • rhabdomyolysis
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