VALPROIC ACID- valproic acid solution 
REMEDYREPACK INC.

----------

MEDICATION GUIDE

VALPROIC ACID ORAL SOLUTION USP

(VAL-pro-IC)

Read this Medication Guide before you start taking valproic acid and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about valproic acid?

Do not stop taking valproic acid without first talking to your healthcare provider.

Stopping valproic acid suddenly can cause serious problems.

Valproic acid can cause serious side effects, including:

1. Serious liver damage that can cause death, especially in children younger than 2 years old.
The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.
Call your healthcare provider right away if you get any of the following symptoms: In some cases, liver damage may continue despite stopping the drug.

2. Valproic acid may harm your unborn baby.

3. Inflammation of your pancreas that can cause death.
Call your healthcare provider right away if you have any of these symptoms:

4. Like other antiepileptic drugs, valproic acid may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop valproic acid without first talking to a healthcare provider.Stopping valproic acid suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is valproic acid?

Valproic acid is a prescription medicine used alone or with other medicines, to treat:

Who should not take valproic acid?

Do not take valproic acid if you:

What should I tell my healthcare provider before taking valproic acid?

Before you take valproic acid, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.

Taking valproic acid with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take valproic acid?

What should I avoid while taking valproic acid?

What are the possible side effects of valproic acid?

Valproic acid can cause serious side effects including:

Call your healthcare provider right away, if you have any of the symptoms listed above.

The common side effects of valproic acid include:

These are not all of the possible side effects of valproic acid. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 Valproic Acid Oral Solution USP?

Keep valproic acid and all medicines out of the reach of children.

General information about the safe and effective use of valproic acid.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use valproic acid for a condition for which it was not prescribed. Do not give valproic acid to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about valproic acid. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about valproic acid that is written for health professionals.

For more information, call Pharmaceutical Associates, Inc. at 1-800-845-8210 or visit www.paipharma.com.

What are the ingredients in Valproic Acid Oral Solution USP?

Active ingredient: valproic acid

Inactive ingredients: cherry flavor, FD&C Red No. 40, glycerin, methylparaben, purified water, sodium hydroxide, sorbitol and sucrose. May also contain citric acid and sodium hydroxide to adjust pH.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

Revised: 3/2024
REMEDYREPACK INC.