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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

21695-843

Regulatory Information

21695-843

ANDA040496

C73584

July 1, 2011

USA

Dolgic Plus Brand of Butalbital, Acetaminophen, and Caffeine Tablets, USP Rx Only

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

118802834

Active Ingredients

BUTALBITAL

Quantity: 50 mg in 1 1

Code: KHS0AZ4JVK

Class Code: ACTIB

ACETAMINOPHEN

Quantity: 750 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

COLLOIDAL SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

D&C RED NO. 27

Code: 2LRS185U6K

Class Code: IACT

D&C RED NO. 30

Code: 2S42T2808B

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CARNAUBA WAX

Code: R12CBM0EIZ

Class Code: IACT

CAFFEINE

Quantity: 40 mg in 1 1

Code: 3G6A5W338E

Class Code: ACTIB

Active Moieties

BUTALBITAL

Code: KHS0AZ4JVK

ACETAMINOPHEN

Code: 362O9ITL9D

CAFFEINE

Code: 3G6A5W338E

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