NDC Code(s) : 55154-7452-6, 55154-7452-4, 55154-7452-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7452(NDC:0143-1787)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Butalbital(UNII: KHS0AZ4JVK)
(Butalbital - UNII:KHS0AZ4JVK) 		Butalbital50 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen325 mg
Caffeine(UNII: 3G6A5W338E)
(Caffeine - UNII:3G6A5W338E) 		Caffeine40 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Magnesium Stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color BLUE (BLUE) Score no score
Shape ROUND (ROUND) Size 11 mm
Flavor Imprint Code Westward;787
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7452-4100 in 1 CARTON
1NDC:55154-7452-61 in 1 POUCH
2NDC:55154-7452-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089718 06/12/1995

PRINCIPAL DISPLAY PANEL

NDC 55154-7452-4

Butalbital, Acetaminophen

and Caffeine tablets, USP

50 mg/325 mg/40 mg

100 Tablets

Each tablet contains:

Butalbital, USP 50 mg

Acetaminophen 325 mg

Caffeine, USP 40 mg

See product insert for complete prescribing information, precautions and warnings.

USUAL ADULT DOSAGE: One or two tablets every four hours. Do not exceed six tablets per day.

STORAGE: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

RX ONLY

WARNING: This package is intended for institutional use only. This package is not child resistant. Keep this and all drugs out of the reach of children.

See window for lot number and expiration date.

Manufactured by: West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC37361470708

Butalbital, Acet. and Caffeine carton

PRINCIPAL DISPLAY PANEL

Butalbital, Acetaminophen

and Caffeine Tablet, USP

50 mg/325 mg/40 mg

Butalbital, Acet. and Caffeine pouch

PRINCIPAL DISPLAY PANEL

Butalbital, Acetaminophen

and Caffeine Tablets, USP

50 mg/325 mg/40 mg

10 Tablets

bag label