GEMFIBROZIL (Page 5 of 5)

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, 600 mg are white, capsule-shaped tablets with the logo “B260” debossed on one side and bisected on the other side of the tablet, each containing 600 mg gemfibrozil, are available as follows:

NDC 42806-260-60: bottles of 60

NDC 42806-260-18: bottles of 180

NDC 42806-260-05: bottles of 500

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Protect from light and humidity.

Dispense in a tight container as defined in the USP.

Distributed by:

Epic Pharma, LLC

Laurelton, NY 11413 USA

Rev. 07-2021-00
MF260REV07/21
BP0143-03

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg 60ct

Gemfibrozil Tablets USP, 600 mg

Rx Only

60 Tablets

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg 500ct

Gemfibrozil Tablets USP, 600 mg

Rx Only

500 Tablets

GEMFIBROZIL gemfibrozil tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-260 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 CALCIUM STEARATE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 3350 POLYVINYL ALCOHOL STARCH, CORN SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE

Product Characteristics Color white Score 2 pieces Shape OVAL Size 20mm Flavor Imprint Code B260 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42806-260-60 60 TABLET in 1 BOTTLE None 2 NDC:42806-260-18 180 TABLET in 1 BOTTLE None 3 NDC:42806-260-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078012 03/23/2017

Labeler — Epic Pharma, LLC (827915443)

Registrant — Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe (080230346)

Establishment
Name	Address	ID/FEI	Operations
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe		080230346	manufacture (42806-260)

Revised: 12/2022 Epic Pharma, LLC