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.
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.
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 07/2018
PRINCIPAL DISPLAY PANEL
| 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 || |
|# ||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
| 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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