Label: 365 EVERYDAY VALUE ASPIRIN- aspirin tablet, film coated

  • NDC Code(s): 42681-7075-1
  • Packager: Whole Foods Market, INC.
  • 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 November 14, 2018

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

  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves

    headache
    muscle pain
    toothache
    menstrual pain
    pain and fever of colds
    minor pain 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
    asthma (wheezing)
    shock

    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

    Do not use

    if you have ever had an allergic reaction to 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
    you are taking a diuretic
    you have asthma

    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

    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
    pain gets worse or lasts more than 10 days
    redness or swelling is present
    fever lasts more than 3 days
    new symptoms occur
    ringing in the ears or a loss of hearing occurs

    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 (1-800-222-1222).

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  • Directions

    drink a full glass of water with each dose
    adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
    children under 12 years: consult a doctor
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  • Inactive ingredients

    corn starch, dibasic calcium phosphate dihydrate, hypromellose, talc, triacetin

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    CAFFEINE & DYE FREE

    Aspirin 325mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SAFE PAIN RELIEF PLUS LIFESAVING BENEFITS-TALK TO YOUR DOCTOR OR OTHER HEALTHCARE PROVIDER BEFORE USING THIS PRODUCT FOR YOUR HEART

    COMPARE TO THE ACTIVE INGREDIENT IN BAYER®

    FOR ADULTS

    100 COATED TABLETS

    aspirin-image
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  • INGREDIENTS AND APPEARANCE
    365 EVERYDAY VALUE ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42681-7075
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 14mm
    Flavor Imprint Code Aspirin;L
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42681-7075-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/23/2018
    Labeler - Whole Foods Market, INC. (196175616)
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