BUTALBITAL, ASPIRIN, AND CAFFEINE capsule

Butalbital, aspirin, and caffeine by

Drug Labeling and Warnings

Butalbital, aspirin, and caffeine by is a Prescription medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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

    Butalbital, aspirin, and caffeine capsules are dark green and light green in color, imprinted with logo "LANNETT" on the cap and "1552" on the body. Each capsule contains: butalbital USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows:

    Bottles of 100   NDC: 0527-1552-01

    Dispense in a tight container as defined in the USP. Use child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Protect from moisture.

    Distributed by:
    Lannett Company, Inc.
    Philadelphia, PA 19136

    CIB70308D

    Rev. 11/19

  • PRINCIPAL DISPLAY PANEL

    NDC 0527-1552-01

    Butalbital,
    Aspirin, and
    Caffeine
    Capsules

    CIII

    50 mg/325 mg/40 mg

    Rx Only

    100 Capsules

    Lannett

    100 count
  • INGREDIENTS AND APPEARANCE
    BUTALBITAL, ASPIRIN, AND CAFFEINE 
    butalbital, aspirin, and caffeine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0527-1552
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK) BUTALBITAL50 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TRIMYRISTIN (UNII: 18L31PSR28)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREEN (dark green and light green) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code Lannett;1552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0527-1552-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/11/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08699610/11/1985
    Labeler - Lannett Company, Inc. (002277481)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.829757603ANALYSIS(0527-1552)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.006422406LABEL(0527-1552) , MANUFACTURE(0527-1552) , PACK(0527-1552) , RELABEL(0527-1552) , REPACK(0527-1552)

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