Butalbital, Aspirin, and Caffeine (Page 4 of 4)

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Product: 50090-1580

NDC: 50090-1580-0 30 CAPSULE in a BOTTLE

Butalbital, aspirin, and caffeine

Label Image
(click image for full-size original)
BUTALBITAL, ASPIRIN, AND CAFFEINE
butalbital, aspirin, and caffeine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1580(NDC:0527-1552)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
CAFFEINE (CAFFEINE) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TRIMYRISTIN
TALC
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
GELATIN, UNSPECIFIED
SHELLAC
ALCOHOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
METHYL ALCOHOL
FD&C BLUE NO. 2
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C BLUE NO. 1
Product Characteristics
Color green (dark green and light green) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Lannett;1552
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1580-0 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086996 10/11/1985
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1580), REPACK (50090-1580)

Revised: 06/2021 A-S Medication Solutions

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