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:

NDC 51138-588-30 Bottles of 30

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

Manufactured by:
InvaGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

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

Revised: 12/10

Repackage By:
Med-Health Pharma, LLC
North Las Vegas, NV 89032
SP-60186 Rev02

PRINCIPAL DISPLAY PANEL

Gemfibrozil Tablets, USP 600 mg

Gemfibrozil Tablets, USP
                     600 mg/30 Tablets
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51138-588(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)
HYPROMELLOSE 2910 (15000 MPA.S)
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
POLYSORBATE 80
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:51138-588-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 07/04/2011
Labeler — Med-Health Pharma, LLC (962603812)
Establishment
Name Address ID/FEI Operations
Med-Health Pharma, LLC 962603812 repack

Revised: 07/2011 Med-Health Pharma, LLC

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