GABAPENTIN- gabapentin capsule 
ACI Healthcare USA, Inc.



Capsules, USP
100 mg, 300 mg and 400 mg
Rx Only

What is the most important information I should know about gabapentin?

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

Stopping gabapentin suddenly can cause serious problems.

Gabapentin can cause serious side effects including:

1.Suicidal Thoughts. Like other antiepileptic drugs, gabapentin 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 taking gabapentin without first talking to a healthcare provider.

2.Changes in behavior and thinking - Using gabapentin in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3.Gabapentin may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin. You may or may not have a rash with an allergic reaction caused by gabapentin. Call a healthcare provider right away if you have any of the following symptoms:

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin.

4. Serious breathing problems. Serious breathing problems can occur when gabapentin is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting gabapentin or when the dose is increased. Get help right away if breathing problems occur.

What is gabapentin?

Gabapentin is a prescription medicine used to treat:

Who should not take gabapentin?

Do not take gabapentin capsules if you are allergic to gabapentin or any of the other ingredients in gabapentin capsules. See the end of this Medication Guide for a complete list of ingredients in gabapentin capsules.

What should I tell my healthcare provider before taking gabapentin?

Before taking gabapentin, tell your healthcare provider if you:

 o Pregnancy Registry: If you become pregnant while taking gabapentin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid pain medicine (such as oxycodone), any medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem), or any medicines that make you sleepy.

You may have a higher chance for dizziness, sleepiness, or breathing problems if these medicines are taken with gabapentin.

Taking gabapentin 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 when you get a new medicine.

How should I take gabapentin?

    o Do not change your dose of gabapentin without talking to your healthcare provider.

    o Take gabapentin capsules with water.

If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.

What should I avoid while taking gabapentin?

What are the possible side effects of gabapentin?

Gabapentin may cause serious side effects including:

   See "What is the most important information I should know about gabapentin?"

  • lack of coordination
  • viral infection
  • difficulty with speaking
  • tremor
  • swelling, usually of legs and feet
  • feeling tired
  • fever
  • feeling drowsy
  • nausea and vomiting
  • jerky movements
  • difficulty with coordination
  • double vision
  • unusual eye movement

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

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

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 gabapentin?

Keep gabapentin and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin

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

For more information call 1-888-900-1006.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin

Inactive ingredients in the capsules: mannitol, pregelatinized starch, talc, gelatin, titanium dioxide and imprinting ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

The 300-mg capsule shell also contains: yellow iron oxide

The 400-mg capsule shell also contains: FD&C Blue No. 1,FD&C Red No. 3.

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

Manufactured by: Zhejiang Yongtai Pharmaceutical Co., Ltd 

No.1, 8th Donghai Avenue, Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone, Linhai City, Zhejiang Province, 317016, China.

Distributed by:
ACI Healthcare USA, Inc.
10100 W. Sample Road, Suite 406
Coral Springs, FL 33065

The brands listed are the registered trademarks of their respective owners.

Revised 09/2022

Revised: 8/2023
ACI Healthcare USA, Inc.