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

63187-772-60
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-772(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:63187-772-30 30 TABLET in 1 BOTTLE None
2 NDC:63187-772-60 60 TABLET in 1 BOTTLE None
3 NDC:63187-772-90 90 TABLET in 1 BOTTLE None
4 NDC:63187-772-72 120 TABLET in 1 BOTTLE None
5 NDC:63187-772-78 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 07/08/2016
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

Page 4 of 4 1 2 3 4

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.