Label: EXTRA STRENGTH BACK AND BODY- aspirin and caffeine capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 03/13

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

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg (NSAID)*
    Caffeine 32.5 mg

    *nonsteroidal anti-inflammatory drug 

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  • Purpose

    Pain reliever
    Pain reliever aid 

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  • Uses

    for the temporary relief of:

    • backache pain
    • muscle aches and pains
    • minor aches and pains of arthritis 
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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
    • shock
    • asthma (wheezing)

    Stomach bleeing warning: This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

    • have had stomach ulcers or bleeding problems, are age 60 or older
    • take a blood thinning (anticoagulant) or steroid drug
    • take other 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

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have asthma
    • you have high blood pressure, heart disease, lover cirrhosis, or kidney disease
    • you are taking a diuretic 

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for:

    • gout
    • diabetes
    • arthritis

    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
    • an allergic reaction occurs.  Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • 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. 

    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 right away. 

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  • 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 hour
    • children under 12 years: do not use unless directed by a doctor 
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  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate 

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  • Questions or Comments?

    1-800-426-9391 

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  • Principal display panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-0431-15

    EXTRA STRENGTH
    Back & Body
    Aspirin (NSAID) /
    Caffeine / Pain Reliever Aid
    • Fast relief at the site of pain

    50
    COATED CAPLETS

    Compare to Bayer® Back & Body active ingredientsǂǂ

    ǂWalgreens Pharmacist Survey Study, November 2010.
    ǂǂThis product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark Bayer® Back & Body.
    50844    ORG081041315

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

    Walgreens 44-413

    Walgreens 44-413

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH BACK AND BODY 
    aspirin, caffeine capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0431
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 500 mg
    CAFFEINE (CAFFEINE) CAFFEINE 32.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 44;413
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0431-15 1 in 1 CARTON
    1 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 04/12/2004
    Labeler - WALGREEN CO. (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-0431)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-0431)
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