Basic Information
butalbital, acetaminophen and caffeine
63629-2087
Regulatory Information
63629-2087
ANDA212083
C73584
September 21, 2021
USA
Butalbital, Acetaminophen, and Caffeine Capsules, USP
HUMAN PRESCRIPTION DRUG LABEL
103
Company Information
171714327
Active Ingredients
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
Active Moieties
CAFFEINE
Code: 3G6A5W338E
BUTALBITAL
Code: KHS0AZ4JVK
ACETAMINOPHEN
Code: 362O9ITL9D