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. 10-2018-00

MF260REV10/18

BP00143-02

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 600 mg 60ct

Gemfibrozil Tablets USP, 600 mg

Rx Only

60 Tablets

gemfibrozil-600mg-60ct
(click image for full-size original)
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: 05/2019 Epic Pharma, LLC

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