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.
Bottles of 60 NDC 65862-624-60
Bottles of 500 NDC 65862-624-05
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: 12/2020
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 600 mg (60 Tablet Bottle)
NDC 65862-624-60
Rx only
Gemfibrozil
Tablets, USP
600 mg
AUROBINDO 60 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 600 mg (60 Tablet Bottle)
GEMFIBROZIL gemfibrozil tablet, film coated |
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Revised: 07/2021 Aurobindo Pharma Limited
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