Basic Information
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
68258-2012
Regulatory Information
68258-2012
ANDA076560
C73584
September 20, 2011
USA
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules CIII
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
066070785
Active Ingredients
FD&C Blue No. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C Red No. 3
Code: PN2ZH5LOQY
Class Code: IACT
FD&C Red No. 40
Code: WZB9127XOA
Class Code: IACT
FD&C Yellow No. 5
Code: I753WB2F1M
Class Code: IACT
Gelatin
Code: 2G86QN327L
Class Code: IACT
Cellulose, Microcrystalline
Code: OP1R32D61U
Class Code: IACT
Sodium Lauryl Sulfate
Code: 368GB5141J
Class Code: IACT
Stearic Acid
Code: 4ELV7Z65AP
Class Code: IACT
Talc
Code: 7SEV7J4R1U
Class Code: IACT
Titanium Dioxide
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
Acetaminophen
Code: 362O9ITL9D
Caffeine
Code: 3G6A5W338E
Butalbital
Code: KHS0AZ4JVK
Codeine
Code: Q830PW7520