Label: PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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 July 1, 2014

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

  • Active ingredients (in each tablets)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

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  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    a cold
    arthritis
    muscular aches
    sinusitis
    toothache
    premenstrual and menstrual cramps
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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 naussea 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 may cause a severe allergic reaction, which may include:

    hives
    facial swelling
    shock
    asthma (wheezing)

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

    more than 8 tablets in 24 hours, which is the maximum daily amount
    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
    hae had stomach ulcers or bleeding problems
    take a blood thinning (anticoagulant) or steroid drug
    take other drugs containing prescription or nonprescription NSAIDs [aspiring, 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, occasionaly, rapid heartbeat.

    Do not use

    if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
    with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    you have liver disease
    stomach bleeding warning appies to you
    you have a history of stomach problems, such as heartburn
    you have high blood pressure, heart disease, liver cirrhosis or kidney disease

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for diabetes, gout, or arthritis
    taking any other drug or are under a doctor's care for any serious condition

    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.
    any new symptoms appear
    ringing in the ears or loss of hearing occurs
    pain gets worse or lasts for more than 10 days
    fever gets worse or lasts for more than 3 days
    painful area is red or swollen

    If pregnant or breast-feeding,

    ask a health 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    do not use more than directed
    drink a full glass of water with each dose
    adults and children 12 years and over
    take 2 tablets every 6 hours
    do not take more than 8 tablets in 24 hours
    children under 12 years: do not use unless directed by a doctor
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  • Other information

    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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  • Questions or comments?

    (800) 616-2471

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  • Principal Display Panel

    MAJOR®

    COMPARE TO the active ingredients in EXCEDRIN® Extra Strength†

    PAIN RELIEVER
    PLUS
    Acetaminophen, Aspirin (NSAID) and caffeine
    Pain Reliever / Pain Reliever Aid

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excederin® Extra Strength.
    50844       REV0713C15912

    Distributed by MAJOR PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA        M-17          Rev. 08/13
    Re-order No. 252831

    Pain
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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PLUS 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58118-5135(NDC:0904-5135)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code 44;159
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58118-5135-3 30 in 1 BOTTLE, PLASTIC
    2 NDC:58118-5135-6 60 in 1 BOTTLE, PLASTIC
    3 NDC:58118-5135-9 90 in 1 BOTTLE, PLASTIC
    4 NDC:58118-5135-8 30 in 1 BLISTER PACK
    5 NDC:58118-5135-0 1 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/17/1992
    Labeler - Clinical Solutions Wholesale (078710347)
    Registrant - Clinical Solutions Wholesale (078710347)
    Establishment
    Name Address ID/FEI Business Operations
    Clinical Solutions Wholesale 078710347 REPACK(58118-5135) , RELABEL(58118-5135)
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