The recommended dose for adults is 1,200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).
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.
Supplied as White film-coated, capsule shaped, biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and 225 on the other.
NDC 69097-821-03: Bottles of 60
NDC 69097-821-07: Bottles of 100
NDC 69097-821-12: Bottles of 500
Store at controlled room temperature 20° — 25°C (68° — 77°F) [see USP]. Protect from light and humidity. Preserve in tight containers.
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059
To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
|GEMFIBROZIL gemfibrozil tablet|
|Labeler — Cipla USA Inc. (078719707)|
|Registrant — Cipla USA Inc. (078719707)|
|InvaGen Pharmaceutical Inc||165104469||manufacture (69097-821), analysis (69097-821)|
|InvaGen Pharmaceutical Inc||080334903||analysis (69097-821), pack (69097-821)|
Revised: 06/2021 Cipla USA Inc.
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