Gemfibrozil (Page 5 of 5)

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.

HOW SUPPLIED

Product: 50090-6913

NDC: 50090-6913-0 60 TABLET in a BOTTLE

NDC: 50090-6913-2 90 TABLET in a BOTTLE

NDC: 50090-6913-3 30 TABLET in a BOTTLE

NDC: 50090-6913-4 180 TABLET in a BOTTLE

gemfibrozil

Label ImageLabel Image
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-6913(NDC:16714-101)
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
MICROCRYSTALLINE CELLULOSE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
POLYSORBATE 80
SILICON DIOXIDE
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
STARCH, CORN
Product Characteristics
Color WHITE (Off-white) Score 2 pieces
Shape OVAL (elliptical, biconvex) Size 19mm
Flavor Imprint Code N111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-6913-0 60 TABLET in 1 BOTTLE None
2 NDC:50090-6913-4 180 TABLET in 1 BOTTLE None
3 NDC:50090-6913-2 90 TABLET in 1 BOTTLE None
4 NDC:50090-6913-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079072 12/20/2010
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-6913), REPACK (50090-6913)

Revised: 12/2023 A-S Medication Solutions

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.