Label: MEDIQUE PAIN OFF- acetaminophen, aspirin, caffeine tablet, film coated

  • NDC Code(s): 47682-228-13, 47682-228-33, 47682-228-47, 47682-228-64, view more
    47682-228-69, 47682-228-99
  • Packager: Unifirst First Aid Corporation
  • 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 May 11, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients (in each tablet)

    Acetaminophen 250 mg

    Aspirin (NSAID*) 250 mg

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Pain reliever aid

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  • Uses:

    • headache
    • muscular aches
    • minor arthritis pain
    • back pain
    • common cold
    • toothache
    • menstrual cramps

    Temporarily reduces fever.

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

    ■ hives

    ■ facial swelling

    ■ asthma (wheezing)

    ■ shock

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening

    ■ blisters

    ■ rash

    If a skin or 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 4,0000 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 more than 3 days for fever 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
    • you have asthma

    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 appear

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin 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 do not notice any signs or symptoms.

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  • Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years:

    Do not give to children under 12 years of age.

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  • Other information

    • read all product information before using
    • store at room temperature 59°-86°F (15°-30°C)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

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

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  • Questions or comments? 1-800-634-7680
  • Medique Pain-Off Label

    Medique®

    Pain-Off

    Extra Strength Pain Relief

    Pull to Open

    Aches, Fever • Acetaminophen 250 mg

    Aspirin (NSAID) 250 mg

    Pain Reliever Aid • Caffeine 65 mg

    100 Tablets

    (50 x 2)

    Tamper Evident Unit Dose Packets

    Medique Pain-Off Label 2

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  • INGREDIENTS AND APPEARANCE
    MEDIQUE PAIN OFF 
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-228
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 11mm
    Flavor Imprint Code FR;9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-228-64 12 in 1 BOX, UNIT-DOSE 12/30/2008
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:47682-228-33 50 in 1 BOX, UNIT-DOSE 12/30/2008
    2 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:47682-228-47 100 in 1 BOX, UNIT-DOSE 12/30/2008
    3 2 in 1 PACKET; Type 0: Not a Combination Product
    4 NDC:47682-228-13 250 in 1 BOX, UNIT-DOSE 12/30/2008
    4 2 in 1 PACKET; Type 0: Not a Combination Product
    5 NDC:47682-228-69 3 in 1 BOX, UNIT-DOSE 12/30/2008
    5 NDC:47682-228-99 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)
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