Gabapentin (Page 10 of 10)

What are the possible side effects of gabapentin?

• See “What is the most important information I should know about gabapentin?”
• The most common side effects of gabapentin include:

  • dizziness

  • lack of coordination

  • viral infection

  • feeling drowsy

  • feeling tired

  • fever

  • jerky movements

  • difficulty with speaking

  • temporary loss of memory (amnesia)

  • tremor

  • 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?

• Store Gabapentin Tablets USP between 59°F to 86°F (15°C to 30°C).

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 about gabapentin, go to www.glenmarkgenerics.com. For medical inquiries or to report side effects regarding gabapentin, please call 1 (888)721-7115.

What are the ingredients in gabapentin?

Active ingredient: gabapentin USP

Inactive ingredients in the tablets: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water.

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

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

June 2011

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Principal Display Panel

GABAPENTIN gabapentin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-789(NDC:68462-126) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN COPOVIDONE K25-31 POLOXAMER 407 MAGNESIUM STEARATE POLYETHYLENE GLYCOL HYPROMELLOSES TITANIUM DIOXIDE TALC POLYSORBATE 80 WATER

Product Characteristics Color WHITE (White to off-white) Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code G;31 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52959-789-02 120 TABLET (TABLET) in 1 BOTTLE None 2 NDC:52959-789-30 30 TABLET (TABLET) in 1 BOTTLE None 3 NDC:52959-789-60 60 TABLET (TABLET) in 1 BOTTLE None 4 NDC:52959-789-63 63 TABLET (TABLET) in 1 BOTTLE None 5 NDC:52959-789-90 90 TABLET (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077662 04/01/2006

GABAPENTIN gabapentin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-772(NDC:68462-127) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 800 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN COPOVIDONE K25-31 POLOXAMER 407 MAGNESIUM STEARATE POLYETHYLENE GLYCOL HYPROMELLOSES TITANIUM DIOXIDE TALC POLYSORBATE 80 WATER

Product Characteristics Color WHITE (White to off-white) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code G;13 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52959-772-02 120 TABLET (TABLET) in 1 BOTTLE None 2 NDC:52959-772-30 30 TABLET (TABLET) in 1 BOTTLE None 3 NDC:52959-772-60 60 TABLET (TABLET) in 1 BOTTLE None 4 NDC:52959-772-90 90 TABLET (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077662 04/01/2006

Labeler — H.J. Harkins Company, Inc. (147681894)

Registrant — Glenmark Generics Inc., USA (835917282)

Establishment
Name	Address	ID/FEI	Operations
Glenmark Generics Limited		677318665	MANUFACTURE, ANALYSIS

Revised: 04/2012 H.J. Harkins Company, Inc.