PAIN FREE PLUS (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [AFASSCO INC.]

PAIN FREE PLUS (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [AFASSCO INC.]
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NDC 51532-0560-2
Set ID 9968232c-6039-4f4a-a51d-093c543192db
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

  • PURPOSE

    Pin reliever, Stimulant

  • INDICATIONS & USAGE

    Uses: For the temporary relief of pain from:

    • headaches • muscular aches

    • menstrual cramps • toothaches

    • minor arthritic pain • colds

  • WARNINGS

    WARNING:

    Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.

    Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours

    • with other drugs containing acetaminophen (prescription or non-prescription)

    • 3 or more alcoholic drinks every day while using this product.

    Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug

    • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.

    Children under 12 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

  • PRINCIPAL DISPLAY PANEL

    image description

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  • INGREDIENTS AND APPEARANCE
    PAIN FREE PLUS 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-0560-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/25/2016
    Labeler - Afassco Inc. (609982723)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(51532-0560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(51532-0560)

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