Intended for U.S. healthcare professionals only.
For corporate information, please visit Mallinckrodt.com.
Methylphenidate Hydrochloride Extended-Release Tablets, USP (CII) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.
WARNING: DRUG DEPENDENCE
Methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
|Description||Red Capsule shaped tablet|
|Dosage Strength||54 mg|
|Compares To||Concerta® 54 mg Tablet|
|Identification Code||Imprinted with "M" in a box and “54” on one side in black ink|
* On November 13, 2014, the FDA changed the therapeutic equivalence (TE) rating for this product from AB to BX. This means that the product is presumed to be therapeutically inequivalent to the referenced product until the agency determines there is adequate information to make a full evaluation of TE. The FDA has not identified any serious safety concerns with this product. Mallinckrodt strongly disagrees with the BX rating and is contesting the change.
|NDC #||Package Size||Case Quantity|
For additional information on Methylphenidate HCl Extended-Release Tablets, USP CII 54 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.