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

Gemfibrozil Tablets USP are supplied as:

600 mg: White to off-white, elliptical, biconvex, film-coated tablets with ‘N111’ debossed and scored on one face and scored on the other face.

Bottles of 60 NDC 16714-101-02
Bottles of 500 NDC 16714-101-05


Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and humidity.


KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
Manufactured for: Northstar Rx LLC
Memphis, TN38141

Toll Free Number: 1-800-206-7821
Manufactured by : Piramal Pharma Limited
Plot No. 67-70, Sector -2, Pithampur 454775, Dist. Dhar,
Madhya Pradesh, INDIA.

December 2020

Principal Display Panel Gemfibrozil Tablets USP, 600 mg — 60’s Pack

//medlibrary.org/lib/images-rx/gemfibrozil-18/gemfibrozil-fig2-300x115.jpg
(click image for full-size original)

Rx Only
NDC 16714-101 -02
Gemfibrozil Tablets USP, 600 mg
60 Tablets
NORTHSTARX®
Each tablet contains 600 mg of gemfibrozil USP.
USUAL DOSAGE: See package outsert for full prescribing information.
Dispense in tight container as defined in the USP.
Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and humidity.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Product of India
Manufactured for: Northstar Rx LLC
Memphis, TN38141
Manufactured by: Piramal Pharma Limited
Plot No. 67-70, Sector-2, Pithampur 454775, Dist. Dhar, Madhya Pradesh, INDIA.
Mfg. Lic. No.: 25/10/92 20614751 EM 14725/e Rev 10/2020

Bar Code © 2018 Northstar Healthcare Holdings Ltd

GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSES
POLYSORBATE 80
SILICON DIOXIDE
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE
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:16714-101-02 60 TABLET in 1 BOTTLE None
2 NDC:16714-101-05 500 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 — Northstar RxLLC (830546433)
Registrant — Piramal Pharma Limited (862202793)

Revised: 01/2021 Northstar RxLLC

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 © 2021. All Rights Reserved.