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

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