Basic Information
Butalbital, aspirin, and caffeine
0527-1552
Regulatory Information
0527-1552
ANDA086996
C73584
January 30, 2024
USA
Butalbital, Aspirin, and Caffeine Capsules CIIIRx Only
HUMAN PRESCRIPTION DRUG LABEL
17
Company Information
002277481
Active Ingredients
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TRIMYRISTIN
Code: 18L31PSR28
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
FD&C GREEN NO. 3
Code: 3P3ONR6O1S
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
METHYL ALCOHOL
Code: Y4S76JWI15
Class Code: IACT
ALUMINUM OXIDE
Code: LMI26O6933
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
Active Moieties
CAFFEINE
Code: 3G6A5W338E
ASPIRIN
Code: R16CO5Y76E
BUTALBITAL
Code: KHS0AZ4JVK