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FDA Product

Butalbital, Acetaminophen and Caffeine

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

Basic Information

Butalbital, Acetaminophen and Caffeine

13107-075

Regulatory Information

13107-075

ANDA204733

C73584

September 10, 2019

USA

Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only

Human Prescription Drug Label

2

Company Information

829084461

Active Ingredients

ACETAMINOPHEN

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CAFFEINE

Code: 3G6A5W338E

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