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

  • NDC Code(s): 50844-338-22
  • Packager: L.N.K. International, 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 October 22, 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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  • Uses

    • 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 controlled room temperature 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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  • Questions or comments?

    Call 1-800-426-9391

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  • Principal Display Panel

    QUALITY
    PLUS

    NDC 50844-338-22

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

    EXTRA STRENGTH
    Backache
    Relief
    Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

    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           REV0810B33822

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788

    Quality Plus 44-338

    Quality Plus 44-338

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  • INGREDIENTS AND APPEARANCE
    BACKACHE RELIEF  EXTRA STRENGTH
    magnesium salicylate tetrahydrate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-338
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (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:50844-338-22 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 - L.N.K. International, Inc. (038154464)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(50844-338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(50844-338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(50844-338)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(50844-338)
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