Label: BACKACHE RELIEF- magnesium salicylate tetrahydrate tablet, film coated

  • 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 14, 2018

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

  • Active ingredient (in each caplet)

    Magnesium salicylate tetrahydrate 580 mg (NSAID)*
    (equivalent to 467.2 mg of anhydrous magnesium salicylate)

    *nonsteroidal anti-inflammatory drug 

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  • Purpose

    Pain Reliever 

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  • Use

    for the temporary relief of minor backache pain 

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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

    Stomach bleeding warning: This product contains 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 other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed 

    Do not use

    if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • 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 have asthma
    • you are taking a diuretic 

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis 

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs.  Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present

    These could be signs of a serious condition. 

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use magnesium salicylate 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. 

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  • Directions

    • drink a full glass of water with each dose
    • adults: 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
    • children under 12 years: do not use unless directed by a doctor 
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  • Other information

    • each caplet contains: magnesium 50 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

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  • Principal Display Panel

    RITE AID
    PHARMACY®

    **Compare to the active ingredient in Extra Strength Doan's®

    EXTRA STRENGTH

    pain relief
    backache relief
    magnesium salicylate tetrahydrate (NSAID) 580 mg
    pain reliever

    relieves
    backache
    pain

    48 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    **This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Doan's®.
    50844    REV0512A33822

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE
    CAMP HILL, PA 17011

    IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.


    Rite Aid 44-338

    Rite Aid 44-338

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  • INGREDIENTS AND APPEARANCE
    BACKACHE RELIEF 
    magnesium salicylate tetrahydrate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0338
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 580 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code 44;338
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0338-2 6 in 1 CARTON 11/07/1998
    1 8 in 1 BLISTER PACK; 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 11/07/1998
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(11822-0338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(11822-0338)
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