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, 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 24658-260-30: bottle of 30 Tablets

NDC 24658-260-60: bottle of 60 Tablets

NDC 24658-260-90: bottle of 90 Tablets

NDC 24658-260-18: bottle of 180 Tablets

NDC 24658-260-05: bottle of 500 Tablets

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:

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Laurelton, NY 11413

Rev. 04-2020-00

MF260BLUREV04/20

BP0200-00

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — Gemfibrozil Tablets USP 600 mg — 60 Tablets Container Label

gemfibrozil-600mg-180ct.jpg
(click image for full-size original)
GEMFIBROZIL
gemfibrozil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-260
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (B260) Score 2 pieces
Shape OVAL (capsule-shaped) Size 20mm
Flavor Imprint Code B260
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-260-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:24658-260-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:24658-260-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:24658-260-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:24658-260-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078012 04/01/2011
Labeler — PuraCap Laboratories LLC dba Blu Pharmaceuticals (080210964)
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 (24658-260)

Revised: 11/2020 PuraCap Laboratories LLC dba Blu Pharmaceuticals

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