Label: DOANS EXTRA STRENGTH- magnesium salicylate tablet

  • NDC Code(s): 55741-224-24
  • Packager: Dr. Reddy's Laboratories 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 June 15, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each caplet)

    Magnesium salicylate tetrahydrate 580 mg (NSAID)1 (equivalent to 467.2 mg of anhydrous magnesium salicylate)


    1
    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 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 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:
      • vomit blood
      • feel faint
      • have bloody or black stools
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • redness or swelling is present
    • 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

    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 (1-800-222-1222) 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • each caplet contains: magnesium 50 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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?

    1-800-790-6417

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  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Box

    NDC 55741-224-24

    EXTRA STRENGTH

    DOAN'S®
    MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)
    PAIN RELIEVER

    RELIEVES
    BACKACHE
    PAIN

    24 CAPLETS

    Principal Display Panel - 24 Caplet Bottle Box
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  • INGREDIENTS AND APPEARANCE
    DOANS   EXTRA STRENGTH
    magnesium salicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55741-224
    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 DOANS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55741-224-24 1 in 1 BOX 05/24/2016
    1 24 in 1 BOTTLE; 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 05/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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