Label: BACK RELIEF- acetaminophen, magnesium salicylate tablet

  • NDC Code(s): 0498-2101-01, 0498-2101-10, 0498-2102-01, 0498-2102-10
  • Packager: Honeywell Safety Products USA, 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 August 27, 2018

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

  • Active Ingredients (in each tablet)

    Acetaminophen 200 mg

    Magnesium salicylate 200 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever, fever reducer

    Pain reliever, fever reducer

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  • Uses

    temporary reduces fever and relieves minor aches and pains due to

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

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  • 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.

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  • 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

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  • 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
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  • Inactive Ingredients

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

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  • Questions or comments

    1-800-430-5490

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  • Back Relief label
  • 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)
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