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

gem-600mg-60tabs
(click image for full-size original)

NDC 71209-008-08
Gemfibrozil
Tablets, USP
600 mg
Rx only 180 Tablets

gem-600mg-180tabs
(click image for full-size original)

NDC 71209-008-10
Gemfibrozil
Tablets, USP
600 mg
Rx only
500 Tablets

gem-600mg-500tabs
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71209-008
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
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CALCIUM STEARATE
POLYSORBATE 80
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
SHELLAC
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE
STARCH, CORN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Elliptical) Size 19mm
Flavor Imprint Code C17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71209-008-03 60 TABLET in 1 BOTTLE None
2 NDC:71209-008-08 180 TABLET in 1 BOTTLE None
3 NDC:71209-008-10 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203266 06/17/2016
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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