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 meals (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

Gemfibrozil Tablets, USP are supplied as White film-coated tablets, capsule-shaped, biconvex tablets; Debossed with “I” on the left side of the bisect and “G” on the right side of the bisect on one side and “225” on the other, and available as follows:

Bottles of 60
Bottles of 500

Store at controlled room temperature 20° — 25°C (68° — 77°F) [see USP]. Protect from light and humidity.

Manufactured by:
InvaGen Phamaceuticals, Inc
Hauppauge, NY 11788

Distributed by:
West-ward Pharmaceutical Corp. Eatontown, NJ 07724

Rev. 12/10

PRINCIPAL DISPLAY PANEL

NDC 66336-0367-XX
(click image for full-size original)

NDC 66336-0367-XX
NDC 66336-0367-30

GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-367(NDC:0143-9130)
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
CELLULOSE, MICROCRYSTALLINE
CALCIUM STEARATE
METHYLCELLULOSE (1500 MPA.S)
TITANIUM DIOXIDE
POLYSORBATE 80
POLYETHYLENE GLYCOLS
HYPROMELLOSE 2910 (15000 MPA.S)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code IG;225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66336-367-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 07/27/2006
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (66336-367), repack (66336-367)

Revised: 09/2012 Dispensing Solutions, Inc.

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