Butalbital, Acetaminophen, Caffeine (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

NDC 69367-203-01

Rx Only

Butalbital, Acetaminophen,
and Caffeine Tablets, USP

Each Tablet Contains:
Butalbital, USP
50 mg
Acetaminophen, USP
325 mg
Caffeine, USP
40 mg

100 Tablets

Westminster
Pharmaceuticals

Principal Display Panel -- 100 Tablet Bottle Label
(click image for full-size original)
BUTALBITAL, ACETAMINOPHEN, CAFFEINE
butalbital, acetaminophen, and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-203
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
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STEARIC ACID
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code BAC;123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-203-01 100 TABLET in 1 BOTTLE None
2 NDC:69367-203-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209587 03/05/2019
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 03/2019 Westminster Pharmaceuticals, LLC

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