DIVALPROEX SODIUM- divalproex sodium tablet, delayed release 
Unichem Pharmaceuticals (USA), Inc.

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MEDICATION GUIDE

Divalproex Sodium Delayed Release Tablets, USP

(dye val' proe ex soe' dee um)

Read this Medication Guide before you start taking divalproex sodium delayed release tablets 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 divalproex sodium delayed release tablets?

Do not stop divalproex sodium delayed release tablets without first talking to your healthcare provider.

Stopping divalproex sodium delayed release tablets suddenly can cause serious problems.

Divalproex sodium delayed release tablets 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. Divalproex sodium delayed release tablets 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, Divalproex sodium delayed release tablets 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 Divalproex sodium delayed release tablets without first talking to a healthcare provider.

Stopping divalproex sodium delayed release tablets 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 are Divalproex sodium delayed release tablets?

Divalproex sodium delayed release tablets come in different dosage forms with different usages.

Divalproex sodium delayed release tablets are prescription medicines used:

Who should not take Divalproex sodium delayed release tablets?

Do not take Divalproex sodium delayed release tablets if you:

What should I tell my healthcare provider before taking Divalproex sodium delayed release tablets?

Before you take Divalproex sodium delayed release tablets, 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 divalproex sodium delayed release tablets 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 Divalproex sodium delayed release tablets?

What should I avoid while taking Divalproex sodium delayed release tablets?

What are the possible side effects with Divalproex sodium delayed release tablets?

Divalproex sodium delayed release tablets 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 Divalproex sodium delayed release tablets include:

These are not all of the possible side effects of divalproex sodium delayed release tablets. 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 divalproex sodium delayed release tablets?

Store divalproex sodium delayed release tablets at 20o to 25o C (68o to 77o F).

Keep divalproex sodium delayed release tablets and all medicines out of the reach of children.

General information about the safe and effective use of Divalproex sodium delayed release tablets,

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

For more information, call Unichem Pharmaceuticals (USA), Inc.1-866-562-4616.

What are the ingredients in Divalproex sodium delayed release tablets?

Divalproex sodium delayed release tablets:

Active ingredient: divalproex sodium, USP

Inactive ingredients:

Inactive ingredients:  Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin.

Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin.

Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol.

Individual tablets also contain:

125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide.

250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

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

Additional medication guides can be obtained by calling Unichem at 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Ind. Area, Meerut Road,

Ghaziabad - 201 003, India.

Manufactured For:

Image

East Brunswick, NJ 08816

14-R-06/2020

13012784

Revised: 6/2020
Unichem Pharmaceuticals (USA), Inc.