Label: ADVANCED PAIN RELIEVER- acetaminophen, aspirin tablet

  • NDC Code(s): 67060-560-67, 67060-560-68
  • Packager: ADVANCED FIRST AID, INC.
  • 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 April 7, 2015

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, CAFFEINE (ADJUVANT) 65 MG

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  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER WITH ADJUVANT

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  • INDICATIONS & USAGE

    Uses:

    temporarily relieves minor aches and pains associated with:

    • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

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  • WARNINGS

    Warnings:

    Reye's syndrome:

    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 • you take with other drugs containing acetaminophen (prescription

    or non-prescription)

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

    Stomach Bleeding Warning:

    This product contains nonsteroidal anti-inflammatory drugs (NSAIDs)

    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 • you take more

    or for a longer time than directed

    Do not use:

    • if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an

    allergic reaction to any other pain reliever/fever reducer

    • for pain for more than 10 days or for fever for more

    than 3 days unless directed by a doctor

    • with any other product containing acetaminophen

    Ask doctor before using if you have:

    • asthma • stomach problems (such as heartburn, upset stomach or

    stomach pain)

    • gastric ulcers • bleeding problems

    Ask a doctor or pharmacist before use if

    you are taking a prescription drug for:

    •anticoagulation (thinning of blood) • diabetes • gout • arthritis

    When using this product do not exceed recommended dose.

    Stop use and ask a doctor if:

    • ringing in the ears or loss of

    hearing occurs

    • pain or fever persists or gets worse • new

    symptoms occur

    • redness or swelling is present

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby,

    ask a health professional

    before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

    DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS

    SPECIFIC-ALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT

    MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR

    COMPLICATIONS DURING DELIVERY.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or

    contact a Poison Control Center right away. Prompt medical attention is critical for

    adults as well as for children even if you do not notice any signs or symptoms.

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  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:Take 2 tablets every 6 hours as

     needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

    Children under 12 years: Consult a doctor.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    magnesium stearate, microcrystalline cellulose, povidone,

    sodium starch glycolate, starch and stearic acid

    Mfd For: Advanced First Aid, Baltimore, MD 21237

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  • INGREDIENTS AND APPEARANCE
    ADVANCED PAIN RELIEVER 
    acetaminophen, aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-560
    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 
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CAFFEINE (UNII: 3G6A5W338E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white (SNOW 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:67060-560-68 100 in 1 CARTON 04/07/2015
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:67060-560-67 250 in 1 CARTON 04/07/2015
    2 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/07/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRA SEAL CORPORATION 085752004 pack(67060-560)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-560)
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