Label: MEDIQUE AT HOME BACK PAIN RELIEF- magnesium salicylate tablet, film coated

  • NDC Code(s): 47682-747-33
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Magnesium Salicylate Tetrahydrate (NSAID)* 580 mg

    (equivalent to 467.2 mg of anhydrous magnesium salicylate)

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor backache pain

  • WARNINGS

    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 alcohol drinks every day while using this product

    ■ take more or for a longer time than directed

  • DO NOT USE

    Do not use if you are allergic to salicylates (including aspirin) or to any other pain reliever/fever reducer.

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    ■ gout

    ■ diabetes

    ■ arthritis

  • STOP USE

    Stop use and ask a doctor if

    ■ an allergic reaction occurs. Seek medical help right away.

    ■ 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

    ■ if ringing in the ears or loss of hearing occurs

    ■ new symptoms occur

    ■ 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in 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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ drink a full glass of water with each dose

    Adults and children: (12 years and over) Take 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

  • OTHER SAFETY INFORMATION

    Other information

    ■ each caplet contains: magnesium 40 mg

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    TAMPER EVIDENT child resistant packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique® @ Home

    Back Pain Relief

    Magnesium Salicylate Tetrahydrate

    (NSAID) 580 mg

    Pain Reliever

    Pull to Open

    Child-Resistant Packets

    *not actual size

    50 Packets

    (2 Caplets Per Packet)

    Medique Home

  • INGREDIENTS AND APPEARANCE
    MEDIQUE AT HOME BACK PAIN RELIEF 
    magnesium salicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE580 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIACETIN (UNII: XHX3C3X673)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;338
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-747-3350 in 1 BOX09/26/2022
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/26/2022
    Labeler - Unifirst First Aid Corporation (832947092)