METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet 
Lupin Pharmaceuticals,Inc.

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What is the most important information I should know about Methylphenidate Hydrochloride tablets?

Methylphenidate Hydrochloride tablets is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate Hydrochloride tablets in a safe place to prevent

misuse and abuse. Selling or giving away Methylphenidate Hydrochloride tablets may harm others and

is against the law.

Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines,

or street drugs.

The following have been reported with use of methylphenidate hydrochloride and other stimulant

medicines:

  1. Heart-related problems :

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Methylphenidate Hydrochloride tablets.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with Methylphenidate Hydrochloride tablets.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Methylphenidate Hydrochloride tablets.

2. Mental (Psychiatric) problems: All Patients

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Methylphenidate Hydrochloride tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is Methylphenidate Hydrochloride tablets?

It is not known if Methylphenidate Hydrochloride tablets are safe and effective in children under 6 years of age.

Who should not take Methylphenidate Hydrochloride tablets?

Methylphenidate Hydrochloride tablets should not be taken if you or your child:

Methylphenidate Hydrochloride tablets may not be right for you or your child. Before starting Methylphenidate Hydrochloride tablets, tell your or your child's doctor about all health conditions (or a family history of) including:

Tell your doctor about all of the medicines that you or your child takes including prescription and over-the- counter medicines, vitamins, and herbal supplements. Methylphenidate Hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methylphenidate Hydrochloride tablets.

Your doctor will decide whether Methylphenidate Hydrochloride tablets can be taken with other medicines.

Especially tell your doctor if you or your child takes:

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Methylphenidate Hydrochloride tablets without talking to your doctor first.

How should Methylphenidate Hydrochloride tablets be taken?

What are the possible side effects of Methylphenidate Hydrochloride tablets?

Methylphenidate Hydrochloride tablets may cause serious side effects, including:

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Methylphenidate Hydrochloride tablets?

General information about the safe and effective use of Methylphenidate Hydrochloride tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about Methylphenidate Hydrochloride tablets that is written for healthcare professionals. Do not use Methylphenidate Hydrochloride tablets for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.

What are the ingredients in Methylphenidate Hydrochloride tablets?

Active ingredient: Methylphenidate HCl

Inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (potato), magnesium stearate, and talc

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

SAP code: 263683

Rev. 02/2020


This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 02/2020

Revised: 11/2020
Lupin Pharmaceuticals,Inc.