Label: BAYER GENUINE ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 47682-456-47, 47682-456-50
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 7, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • colds
    • minor pain of arthritis
    • 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 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 are allergic to aspirin or any other any other pain reliever/ fever reducer
    • if you have ever had an allergic reaction to this product or any of its ingredients

    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 loss of hearing occurs

    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 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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  • Other information

    • save carton for full directions and warnings
    • store at room temperature
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  • Inactive ingredients

    corn starch, hypromellose, powdered cellulose, triacetin

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  • Questions or comments?

    1-800-331-4536

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  • Bayer Aspirin Label

    Genuine Aspirin

    Bayer ®

    Aspirin (NSAID) Pain Reliever/Fever Reducer

    The Wonder Drug ®

    325 mg

    Safe Pain Relief Plus

    Lifesaving Benefits

    50

    Coated Tablets

    To Open,

    Push in Tab and Pull Out

    50 Pouches of 2 Tablets Each

    Bayer Aspirin Label 18

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  • INGREDIENTS AND APPEARANCE
    BAYER GENUINE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-456
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code BAYER;BAYER
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-456-50 25 in 1 BOX, UNIT-DOSE 01/24/2014
    1 2 in 1 POUCH; Type 0: Not a Combination Product
    2 NDC:47682-456-47 100 in 1 BOX, UNIT-DOSE 01/24/2014
    2 2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/24/2014
    Labeler - Unifirst First Aid Corporation (832947092)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    Name Address ID/FEI Business Operations
    Bayer Healthcare LLC 072827066 manufacture(47682-456)
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