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

Gemfibrozil Tablets USP, 600 mg are white to off-white, elliptical, biconvex, film-coated tablets, debossed with ‘E’ on one side and ‘82’ on the other side.
Blistercards of 30 NDC 0615-8354-39

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and humidity.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 07/2018

PRINCIPAL DISPLAY PANEL

Gemfibrozil 600mg tab bingo card label
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8354(NDC:65862-624)
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
CALCIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score no score
Shape OVAL (Elliptical, Biconvex) Size 19mm
Flavor Imprint Code E;82
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8354-39 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202726 09/16/2015
Labeler — NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack (0615-8354)

Revised: 08/2022 NCS HealthCare of KY, LLC dba Vangard Labs

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