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
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
Active Moieties
BUTALBITAL
Code: KHS0AZ4JVK
ACETAMINOPHEN
Code: 362O9ITL9D
CAFFEINE
Code: 3G6A5W338E