Label: PERCOGESIC- magnesium salicylate tablet, 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 December 14, 2017

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

  • Drug Facts
  • Active ingredient (in each tablet)

    Magnesium salicylate tetrahydrate 580 mg (NSAID)*


    *nonsteroidal anti-inflammatory drug (equivalent to
    467 mg of magnesium salicylate anhydrous)

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  • Purpose

    Pain reliever

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  • Uses

    Temporarily relieves minor aches and pains associated with

    • backache
    • muscular aches
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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 a
    nonsteroidal anti-inflammatory drug (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
    • right before or after heart surgery

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn, upset stomach or stomach pain
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you have asthma
    • you are taking a diuretic
    • you are on a magnesium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis
    • anticoagulation (thinning the blood)

    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.

    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

    do not take more than 4 doses in 24 hours. Drink a full glass of water with each dose.

    Adults and children 12 years of age and older: take 2 tablets every 6 hours while symptoms persist.

    Children under 12 years of age: ask a doctor

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  • Other information

    • store at room temperature
    • protect from moisture
    • Magnesium content: 40 mg per tablet
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  • Inactive ingredients

    croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, silica, stearic acid, talc, titanium dioxide

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  • Questions?

    1-800-443-4908

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  • PRINCIPAL DISPLAY PANEL

    PERCOGIS MAXIMUM STRENGTH BACKACHE RELIEF

    48 COATED CAPLETS

    Percogesic Backache Relief 48 ct Carton

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  • INGREDIENTS AND APPEARANCE
    PERCOGESIC 
    magnesium salicylate tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-051
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 467 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code BR
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-051-48 1 in 1 CARTON 01/05/2010
    1 48 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 01/05/2010
    Labeler - Medtech Products Inc. (122715688)
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