Label: PAIN AID BRF - magnesium salicylate and acetaminophen tablet

  • NDC Code(s): 35418-801-02, 35418-801-67, 35418-801-68
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/12

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

  • ACTIVE INGREDIENT

    Active Ingredient/TabletAcetaminophen 250mg, Magnesium Salicylate Tetrahydrate 250 mg (NSAID)

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  • PURPOSE

    Purpose-Pain Reliever

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  • INDICATIONS & USAGE

    Temporarily relieves minor back pain

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  • DOSAGE & ADMINISTRATION

    Adults: Take 2 tablets every 6 hours, not more than 8 tablets in 24 hours

    Children under 12 years, ask a doctor


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  • 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.

    Allergy Alert: Magnesium Salicylate may cause a severe allergic reaction which may include: Hives, facial swelling, asthma (wheezing), shock

    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 nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure.  
    •    3 or more alcoholic drinks every day while using this product
    Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding.  The chance is higher if you:
    o    are age 60 or older
    o    have had stomach ulcers or bleeding problems
    o    take a blood thinning (anticoagulant) or steroid drug
    o    take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others.
    o    Take more or for a longer time than directed

    Ask a doctor before use if : Stomach bleeding warnings apply to you, you have a history of stomach problems such as heartburn, you have asthma, high blood pressure, heart disease, liver disease or kidney disease______________________________________________________________
    Do not use:
    •    with any other product containing acetaminophen this will provide more  
    than the recommended dose (overdose) of acetaminophen and could  
    cause serious health concerns.  
    •    for more than 10 days for pain unless directed by a doctor
    •    for more than 3 days for fever unless directed by a doctor
    •    When using this product do not exceed recommended dose.
    _Do not use:
    •    if you are allergic to aspirin or salicylates
    •    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
    ______________________________________________________________
    Stop use and ask a doctor if:
    •    symptoms do not improve
    •    pain or fever persists or gets worse
    •    new symptoms occur
    •    redness or swelling is present

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:
    •    anticoagulation (thinning of blood)
    •    diabetes
    •    gout
    •    arthritis

    Stop use and ask a doctor if:
               An allergic reaction occurs.  Seek medical help right away.
               You experience any of the following signs of stomach bleeding:
               feel faint, vomit blood, have black or bloody stools, have stomach pain that does not get better
    •    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 SPECIFICALLY 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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  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, DC Yellow 10, FDC Yellow 6, microcrystalline cellulose,  polydextrose, povidone, propylene glycol, silicon dioxide, stearic acid, titanium dioxide

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  • PRINCIPAL DISPLAY PANEL

    MM1BRF, 250 Box

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  • INGREDIENTS AND APPEARANCE
    PAIN AID BRF 
    acetaminophen magnesium salicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-801
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SALICYLATE (SALICYLIC ACID) MAGNESIUM SALICYLATE 250 mg
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    STEARIC ACID  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOL 300  
    POVIDONE  
    SILICON DIOXIDE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color orange (light orange) Score no score
    Shape ROUND (FR40) Size 12mm
    Flavor Imprint Code FR40
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-801-68 50 in 1 CARTON
    1 NDC:35418-801-67 125 in 1 CARTON
    1 NDC:35418-801-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/19/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-801)
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