Gemfibrozil (Page 5 of 5)

DOSAGE AND ADMINISTRATION

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).

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 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.

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Revised:01/2021

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69097-821-03 Rx Only

GEMFIBROZIL

Tablets, USP

600 mg

60 Tablets

Cipla

image
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-821
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
CROSCARMELLOSE SODIUM
CALCIUM STEARATE
MICROCRYSTALLINE CELLULOSE
METHYLCELLULOSE (15 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 225;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69097-821-03 60 TABLET in 1 BOTTLE None
2 NDC:69097-821-07 100 TABLET in 1 BOTTLE None
3 NDC:69097-821-12 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 10/13/2016
Labeler — Cipla USA Inc. (078719707)
Registrant — Cipla USA Inc. (078719707)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 165104469 manufacture (69097-821), analysis (69097-821)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceutical Inc 080334903 analysis (69097-821), pack (69097-821)

Revised: 06/2021 Cipla USA Inc.

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 © 2023. All Rights Reserved.