Label: PAIN FREE PLUS- acetaminophen, aspirin, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 28, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

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  • PURPOSE

    Pin reliever, Stimulant

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  • INDICATIONS & USAGE

    Uses: For the temporary relief of pain from:

    • headaches • muscular aches

    • menstrual cramps • toothaches

    • minor arthritic pain • colds

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • 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.

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  • INACTIVE INGREDIENT

    SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

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  • INGREDIENTS AND APPEARANCE
    PAIN FREE PLUS 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0560
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code FR9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51532-0560-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 10/25/2016
    Labeler - Afassco Inc. (609982723)
    Registrant - ULTRAtab Laboratories, Inc. (151051757)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture(51532-0560)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 pack(51532-0560)
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