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MEDIQUE Back Pain Off (Unifirst First Aid Corporation)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 250 PACKET in 1 BOX, UNIT-DOSE (47682-073-13) > 2 TABLET, FILM COATED in 1 PACKET (47682-073-99) Label Information
TABLET, FILM COATED 50 PACKET in 1 BOX, UNIT-DOSE (47682-073-33) > 2 TABLET, FILM COATED in 1 PACKET (47682-073-99) Label Information
TABLET, FILM COATED 100 PACKET in 1 BOX, UNIT-DOSE (47682-073-47) > 2 TABLET, FILM COATED in 1 PACKET (47682-073-99) Label Information

Complete MEDIQUE Back Pain Off Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients (in each tablet)

    Magnesium Salicylate (NSAID*) 290 mg

    magnesium (total) 19 mg

    Acetaminophen 250 mg

    Caffeine 50 mg

    *nonsteroidal anti-inflammatory drug


  • Purposes

    Analgesic

    Pain reliever/fever reducer

    Pain reliever aid


  • Uses

    For the temporary relief of minor aches and pains associated with:

    • back pain
    • muscular aches

  • 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: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

    • hives
    • skin reddening
    • facial swelling
    • rash
    • asthma (wheezing)
    • shock
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

    Do not use
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for pain for more than 10 days unless directed by a doctor
    • for fever for more than 3 days unless directed by a doctor
    • if you ever have had an allergic reaction to any other pain relievers/ fever reducers
    • right before or after heart surgery
    • if you are taking prescription drugs for gout, diabetes, or arthritis

    Ask a doctor before use if
    • stomach bleeding warning applies to you
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have a history of stomach problems such as heartburn

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product
    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if:
    • 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
    • symptoms do not improve
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or loss of hearing occurs
    • redness or swelling is present in the painful area
    • any new symptoms appears

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use salicylates (NSAIDs) 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Directions

    • do not use more than directed

    Adults and children (12 years and older): Take 2 tablets with water every 6 hours while symptoms persist. Do not exceed 8 tablets in 24 hours.

    Children under 12 years: Do not give to children under 12 years of age.


  • Other information

    • each dose contains 38mg of magnesium
    • read all product information before using
    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets

  • Inactive ingredients

    hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid


  • Questions or comments? 1-800-634-7680


  • Principal Display Panel - 073R Medique Back Pain-Off Label

    Medique®

    Back Pain-Off

    Back Pain Relief

    Pull to Open

    Pain Relief Magnesium Salicylate (NSAID) 290 mg,

    Aches, Fevers Acetaminophen 250 mg

    Pain Reliever Aid Caffeine50 mg

    200 Tablets

    (100 x 2)

    Tamper Evident Unit Dose Packets

    073R Medique Back Pain Off Label


  • INGREDIENTS AND APPEARANCE
    MEDIQUE BACK PAIN OFF 
    magnesium salicylate/acetaminophen/caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-073
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 290 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 50 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 12mm
    Flavor Imprint Code FR;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-073-33 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:47682-073-47 100 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:47682-073-13 250 in 1 BOX, UNIT-DOSE
    3 NDC:47682-073-99 2 in 1 PACKET; 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 12/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)