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
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Labeler — Northstar RxLLC (830546433) |
Registrant — Piramal Pharma Limited (862202793) |
Revised: 01/2021 Northstar RxLLC
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