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FDA Product

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

79739-7028

Regulatory Information

79739-7028

ANDA076560

C73584

August 12, 2020

USA

These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII.Initial U.S. Approval: 1992

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

117549198

Active Ingredients

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

ACETAMINOPHEN

Quantity: 300 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

CODEINE PHOSPHATE

Quantity: 30 mg in 1 1

Code: GSL05Y1MN6

Class Code: ACTIB

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CAFFEINE

Code: 3G6A5W338E

CODEINE ANHYDROUS

Code: UX6OWY2V7J

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