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How is Esgic Tablets Supplied

Esgic ® Tablets (butalbital 50 mg [ Warning: May be habit-forming], acetaminophen 325 mg and caffeine 40 mg) are white, capsule-shaped, single-scored debossed ” ” on one side and “535/11” on the other side, in bottles of 100 tablets, NDC 68308-220-01.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Distributed by:

Mayne Pharma

Greenville, NC 27834

Code 687J00

Rev. 04/2017

ESGIC 
butalbital, acetaminophen and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-220
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
POVIDONE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape OVAL (CAPSULE SHAPED) Size 14mm
Flavor Imprint Code 535;11
Contains
Packaging
# Item Code Package Description
1 NDC:68308-220-01 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089175 05/01/2014
Labeler – Mayne Pharma Inc. (867220261)

 

Mayne Pharma Inc.

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