Gemfibrozil (Page 4 of 4)
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meal (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
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 63187-772-30: Bottles of 30
NDC 63187-772-60: Bottles of 60
NDC 63187-772-90: Bottles of 90
NDC 63187-772-72: Bottles of 120
NDC 63187-772-78: Bottles of 180
Store at controlled room temperature 20° — 25°C (68° — 77°F) [see USP]. Protect from light and humidity.
Manufactured for:
Cipla USA Inc.,
9100 S. Dadeland Blvd., Suite 1500
Miami, FL 33156
Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Revised: 7/2016
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC NDC 63187-772-60: Bottles of 60
Rx ONLY
GEMFIBROZIL
Tablets, USP
600mg
60 Tablets
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Labeler — Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Proficient Rx LP | 079196022 | REPACK (63187-772), RELABEL (63187-772) |
Revised: 04/2022 Proficient Rx LP
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