Gemfibrozil (Page 5 of 5)
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.
DOSAGE & 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).
HOW SUPPLIED
Gemfibrozil Tablets, USP 600 mg: White, elliptical, film-coated, scored tablets, imprinted ‘C17’ on one side,are available as follows:
NDC 71209-008-03: Bottles of 60
NDC 71209-008-08: Bottles of 180
NDC 71209-008-10: Bottles of 500
Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity.
Rx only
Manufactured by:
Cadila Pharmaceuticals Limited,
1389 Trasad Road, Dholka,
District — Ahmedabad, Gujarat, INDIA
Revised: January 2021
PRINCIPAL DISPLAY PANEL
NDC 71209-008-03
Gemfibrozil
Tablets, USP
600 mg
Rx only 60 Tablets
NDC 71209-008-08
Gemfibrozil
Tablets, USP
600 mg
Rx only 180 Tablets
NDC 71209-008-10
Gemfibrozil
Tablets, USP
600 mg
Rx only
500 Tablets
GEMFIBROZIL gemfibrozil tablet | ||||||||||||||||||||||||||||||||||
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Labeler — Cadila Pharmaceuticals Limited (862257719) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Cadila Pharmaceuticals Limited | 918451696 | MANUFACTURE (71209-008) |
Revised: 12/2022 Cadila Pharmaceuticals Limited
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