Gemfibrozil (Page 5 of 5)

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

Elliptical White to Off-White Scored On Both Sides Tablet Debossed: “N111” on one side

NDC 68071-2422-8

Principal Display Panel Gemfibrozil Tablets USP

PDP
(click image for full-size original)

GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2422(NDC:16714-101)
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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSES
POLYSORBATE 80
SILICON DIOXIDE
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE
STARCH, CORN
Product Characteristics
Color white (Off-white) Score 2 pieces
Shape OVAL (elliptical, biconvex) Size 19mm
Flavor Imprint Code N111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2422-8 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079072 12/20/2010
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2422)

Revised: 05/2021 NuCare Pharmaceuticals,Inc.

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