Gemfibrozil (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (see ). CLINICAL PHARMACOLOGY

OVERDOSAGE

There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.

HOW SUPPLIED

NDC:68151-2893-8 in a CUP of 1 TABLETS

GEMFIBROZIL TABLET

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GEMFIBROZIL gemfibrozil tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2893(NDC:31722-225) Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM CALCIUM STEARATE CELLULOSE, MICROCRYSTALLINE METHYLCELLULOSE (15 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 400 POLYSORBATE 80

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code 225;IG Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68151-2893-8 1 TABLET in 1 CUP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077836 01/01/2011

Labeler — Carilion Materials Management (079239644)

Registrant — Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Operations
Carilion Materials Management		079239644	REPACK (68151-2893)

Revised: 03/2015 Carilion Materials Management