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 debossed 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 50268-350-15 (10 Tablets per card, 5 cards per carton)
Dispensed in Unit Dose package. For Institutional Use Only.

Store at controlled room temperature 20°-25°C (68°-77°F) [see USP]. Protect from light and humidity.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 08/17
AV Rev. 01/19 (P) AvPAK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 2
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-350(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
CELLULOSE, MICROCRYSTALLINE
METHYLCELLULOSE (15 CPS)
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:50268-350-15 50 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-350-11)
1 NDC:50268-350-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-350-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 07/10/2014
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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