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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

68258-2012

Regulatory Information

68258-2012

ANDA076560

C73584

September 20, 2011

USA

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules CIII

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

066070785

Active Ingredients

Butalbital

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

Acetaminophen

Quantity: 325 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: ACTIM

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C Red No. 3

Code: PN2ZH5LOQY

Class Code: IACT

FD&C Red No. 40

Code: WZB9127XOA

Class Code: IACT

FD&C Yellow No. 5

Code: I753WB2F1M

Class Code: IACT

Gelatin

Code: 2G86QN327L

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

Sodium Lauryl Sulfate

Code: 368GB5141J

Class Code: IACT

Stearic Acid

Code: 4ELV7Z65AP

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Acetaminophen

Code: 362O9ITL9D

Caffeine

Code: 3G6A5W338E

Butalbital

Code: KHS0AZ4JVK

Codeine

Code: Q830PW7520

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