Label: BACK PAIN RELIEF EXTRA STRENGTH DOANS- magnesium salicylate tablet, film coated

  • NDC Code(s): 84269-2550-2
  • Packager: Wildman Business Group
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 1, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 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
    • 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 sealed 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? (888) 602-0288

  • Principal Display Panel – 50 Caplet Box Label

    2550

    BACK PAIN RELIEF

    Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

    Pain Reliever / Anti-Inflammatory

    Pull to Open

    50 Caplets

    2 Per Packet

    The Provision

    First Aid

    Line™

    BY WILDMAN

    Principal Display Panel – 50 Caplet Box Label
  • INGREDIENTS AND APPEARANCE
    BACK PAIN RELIEF   EXTRA STRENGTH DOANS
    magnesium salicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84269-2550
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;338
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84269-2550-250 in 1 BOX07/01/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2024
    Labeler - Wildman Business Group (016677338)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(84269-2550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794PACK(84269-2550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761PACK(84269-2550)