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BACK RELIEF (North Safety Products LLC)

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TABLET 50 PACKET in 1 CARTON (0498-2101-10) > 2 TABLET in 1 PACKET (0498-2101-01) Label Information

Complete BACK RELIEF Information

  • Active Ingredients (in each tablet)

    Acetaminophen 200 mg

    Magnesium salicylate 200 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug


  • Purpose

    Pain reliever, fever reducer

    Pain reliever, fever reducer


  • Uses

    temporary reduces fever and relieves minor aches and pains due to

    a cold, headache, toothache, muscular aches, arthritis, premenstrual and menstrualcramps,


  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: magnesium salicylate may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma(wheezing)
    • shock

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,00 mg in 24 hours, which is the maximum daily amount,
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while taking this product

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older,
    • have had stomach ulcers or bleeding problems,
    • take a blood thinning (anticoagulant) or steroid drug
    • take any other drugs containing precription or nonprescription NSAIDs (aspirin,ibuprofen,naproxen or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for longer time than directed

    Do not use
    • if you ever had an allergic reaction to acetaminophen, magnesium salicylate or any other pain reliever/ fever reducer
    • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    Ask a doctor before use if
    • you have liver disease
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin

    Stop using and ask a doctor if
    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days'
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present in painful area
    • ringing in the ears or a loss of hearing occurs
    • any new symptoms appear.

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to

    use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor

    because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    Overdose warning:In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years of age and over:
    • take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours
    • children under 12 years:ask a doctor


  • Other Information

    • each tablet contains 19mg of magnesium
    • store at room temperature 15 o-30 oC (59 o-86 oF)
    • avoid excessive heat and humidity
    • TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN

  • Inactive Ingredients

    D&C red #28, microcrystalline cellulose, povidone, starch, stearic acid


  • Questions or comments

    1-800-430-5490


  • Back Relief label

    Honeywell Back Relief


  • INGREDIENTS AND APPEARANCE
    BACK RELIEF 
    acetaminophen, magnesium salicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2101
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    Color pink (Pink) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code FR1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2101-10 50 in 1 CARTON 05/14/2013 12/20/2017
    1 NDC:0498-2101-01 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 05/14/2013 12/20/2017
    BACK RELIEF 
    acetaminophen, magnesium salicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2102
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Product Characteristics
    Color pink (Pink) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code FR1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-2102-10 100 in 1 CARTON 12/20/2017
    1 NDC:0498-2102-01 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 12/20/2017
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 manufacture(0498-2101) , repack(0498-2102)