Label: EXCEDRIN BACK AND BODY- acetaminophen and aspirin tablet, film coated

  • NDC Code(s): 0067-6238-06, 0067-6238-07, 0067-6238-24, 0067-6238-50, view more
    0067-6238-77, 0067-6238-91, 0067-6238-94
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/10

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

  • Active ingredient

    Acetaminophen 250

    Buffered aspirin equal to 250 mg aspirin (NSAID)*

    (buffered with calcium carbonate)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

    Pain reliever

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  • Uses

    • for the temporary relief of minor aches and pains due to:
      • minor pain of arthritis
      • backache
      • muscular aches
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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 may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

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

    • more than 8 caplets 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
    • 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
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  • Do not use

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

    • you have liver disease
    • 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 are taking a diuretic
    • you have asthma
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  • Ask the doctor or pharmacist before use if you are taking

    • any other drug containing an NSAID (prescription or nonprescription)
    • a blood thinning (anticoagulant) or steroid drug.
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor’s care for any serious condition
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  • 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
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear
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  • Pregnancy 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.

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  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center 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  caplets every 6 hours; not more than 8 caplets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • each caplet contains: calcium 80 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • read all product information before using. Keep this box for important information.

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION”

    IS BROKEN OR MISSING

     

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  • Questions

    Questions or comments?1-800-468-7746

     

    Distr. By: Novartis Consumer Health, Inc.

    Parsippany, NJ 07054-0622 ©20XX

    Visit us at www.excedrin.com

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  • Principal Display

    Excedrin Back & Body Extra Strength

    Excedrin Back & Body Extra Strength

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  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  BACK AND BODY
    acetaminophen, aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-6238
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    CELLULOSE, MICROCRYSTALLINE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C BLUE NO. 2  
    HYDROXYPROPYL CELLULOSE  
    HYPROMELLOSE  
    MALTODEXTRIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    POLYDEXTROSE  
    POLYSORBATE 80  
    POVIDONE  
    STARCH, CORN  
    STEARIC ACID  
    TALC  
    ZINC STEARATE  
    Product Characteristics
    Color GREEN (Bi-layer Light & Dark Green) Score no score
    Shape CAPSULE (capsule-shaped tablet) Size 18mm
    Flavor Imprint Code EBB
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6238-06 1 in 1 CARTON
    1 6 in 1 BOTTLE
    2 NDC:0067-6238-24 1 in 1 CARTON
    2 24 in 1 BOTTLE
    3 NDC:0067-6238-50 1 in 1 CARTON
    3 50 in 1 BOTTLE
    4 NDC:0067-6238-91 1 in 1 CARTON
    4 100 in 1 BOTTLE
    5 NDC:0067-6238-77 1 in 1 CARTON
    5 250 in 1 BOTTLE
    6 NDC:0067-6238-94 100 in 1 BOTTLE
    7 NDC:0067-6238-07 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 02/15/2010
    Labeler - Novartis Consumer Health, Inc. (879821635)
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