METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet, chewable 
Camber Pharmaceuticals Inc.

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MEDICATION GUIDE 
Methylphenidate HCl Chewable Tablet, CII
(meth'' il fen' i date hye'' droe klor' ide)

Read the Medication Guide that comes with methylphenidate hydrochloride chewable tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your or your child’s treatment with methylphenidate hydrochloride chewable tablets.

What is the most important information I should know about methylphenidate hydrochloride chewable tablets?

Methylphenidate hydrochloride chewable tablets may cause serious side effects, including:

  • Abuse, misuse, and addiction. Methylphenidate hydrochloride chewable tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride chewable tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride chewable tablets or when it is used in ways that are not approved, such as snorting or injection.
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  • Heart-related problems:
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  • Mental (Psychiatric) problems:

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  • Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
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What Are methylphenidate hydrochloride chewable tablets?
Methylphenidate hydrochloride chewable tablets are a central nervous system stimulant prescription medicine. Methylphenidate hydrochloride chewable tablets are tablets that are made to be chewed and swallowed. They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). Methylphenidate hydrochloride chewable tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate hydrochloride chewable tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate hydrochloride chewable tablets are also used in the treatment of a sleep disorder called narcolepsy.

Methylphenidate hydrochloride chewable tablets are a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep methylphenidate hydrochloride chewable tablets in a safe place to protect it from theft. Never give your methylphenidate hydrochloride chewable tablets to anyone else, because it may cause death or harm them. Selling or giving away methylphenidate hydrochloride chewable tablets may harm others, and is against the law.

Who should not take methylphenidate hydrochloride chewable tablets?
Methylphenidate hydrochloride chewable tablets should not be taken if you or your child:

Methylphenidate hydrochloride chewable tablets should not be used in children less than 6 years old because they have not been studied in this age group.

Methylphenidate hydrochloride chewable tablets may not be right for you or your child. Before starting methylphenidate hydrochloride chewable tablets tell your or your child’s healthcare provider about all health conditions (or a family history of) including:

Tell your healthcare provider if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can methylphenidate hydrochloride chewable tablets be taken with other medicines?

Tell your healthcare provider about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Methylphenidate hydrochloride chewable 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 chewable tablets.

Your healthcare provider will decide whether methylphenidate hydrochloride chewable tablets can be taken with other medicines.

Especially tell your healthcare provider 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 healthcare provider and pharmacist.

Do not start any new medicine while taking methylphenidate hydrochloride chewable tablets without talking to your healthcare provider first.

How should methylphenidate hydrochloride chewable tablets be taken?

  • Chew methylphenidate hydrochloride chewable tablets well and swallow with at least 8 ounces (a full glass) of water or other liquid. Methylphenidate hydrochloride chewable tablets can swell and cause choking if enough liquid is not taken with them. Get emergency medical care if you have chest pain, vomiting, or trouble swallowing, or breathing after taking a methylphenidate hydrochloride chewable tablet.

If you or your child take too much methylphenidate hydrochloride chewable tablets, call your healthcare provider or Poison Helpline, at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are possible side effects of methylphenidate hydrochloride chewable tablets?

See “What is the most important information I should know about methylphenidate hydrochloride chewable tablets?” for information on reported heart and mental problems.
Other serious side effects include:

Common side effects include:

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Talk to your healthcare provider if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your healthcare provider or pharmacist for more information.

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 chewable tablets?

General information about methylphenidate hydrochloride chewable tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride chewable tablets for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride chewable tablets to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about methylphenidate hydrochloride chewable tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about methylphenidate hydrochloride chewable tablets that is written for healthcare professionals. For more information, please contact Camber Pharmaceuticals, Inc. at 1-866-495-8330.

What are the ingredients in methylphenidate hydrochloride chewable tablets?

CAUTION PHENYLKETONURICS: Methylphenidate hydrochloride chewable tablets contain phenylalanine.

Active Ingredient: methylphenidate hydrochloride USP

Inactive Ingredients: aspartame, lactose anhydrous, microcrystalline cellulose, guar gum, grape flavor, pregelatinized starch, and stearic acid.

Medication Guide available at http://camberpharma.com/medication-guides

Manufactured by:
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

This Medication Guide has been approved by the U.S. Food and Drug Administration.                 Revised 09/2023

Revised: 9/2023
Camber Pharmaceuticals Inc.