VALPROIC ACID- valproic acid solution 
Precision Dose Inc.

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MEDICATION GUIDE
Valproic Acid Oral Solution

Read this Medication Guide before you start taking valproic acid oral solution 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 oral solution?

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

Stopping valproic acid oral solution suddenly can cause serious problems.

Valproic acid oral solution 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 oral solution 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 oral solution 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 oral solution without first talking to a healthcare provider. Stopping valproic acid oral solution suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do 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 oral solution?

Valproic acid oral solution is a prescription medicine used:

Who should not take valproic acid oral solution?

Do not take valproic acid oral solution if you:

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

Before you take valproic acid oral solution, 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 oral solution 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 oral solution?

What should I avoid while taking valproic acid oral solution?

What are the possible side effects of valproic acid oral solution?

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

The common side effects of valproic acid oral solution include:

These are not all of the possible side effects of valproic acid oral solution. 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?

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

General information about the safe and effective use of valproic acid oral solution

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use valproic acid oral solution for a condition for which it was not prescribed. Do not give valproic acid oral solution 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 oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about valproic acid oral solution that is written for health professionals.

What are the ingredients in valproic acid oral solution?

Active ingredient: valproic acid

Inactive ingredients: artificial cherry flavor, artificial wild cherry flavor, corn syrup solids, FD&C Red No. 40, glycerin, hydrochloric acid, liquid sugar, methylparaben, potassium phosphate dibasic, propylene glycol, purified water, sodium benzoate and sodium hydroxide

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

Rx Only

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080

LI701 Rev. 10/16

Revised: 10/2017
Precision Dose Inc.