Label: GENUINE ASPIRIN- aspirin tablet, film coated

  • 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 July 27, 2016

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

  • Active ingredient (in each caplet)

    Aspirin 325 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves:
      • headache
      • pain and fever of colds
      • muscle pain
      • menstrual pain
      • toothache
      • 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:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • 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 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 have asthma
    • 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
      • have bloody or black stools
      • vomit blood
      • 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 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 (1-800-222-1222) 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 to 2 caplets every 4 hours. Do not take more than 12 caplets in 24 hours unless directed by a doctor
    • 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, hypromellose, polyethylene glycol, propylene glycol

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  • Questions or comments?

    1-800-426-9391

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  • Principal display panel

    ♥︎CVS
    Health™

    Compare to the active ingredient in Genuine Bayer® Regular Strength†

    Coated Caplets

    NDC 59779-389-12

    Genuine
    Aspirin
    325 mg
    Pain reliever, Fever reducer (NSAID)
    Fast, safe pain relief
    • Headaches  
    • Everyday aches & pains

    100 COATED CAPLETS

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
    #271250

    †This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Regular Strength.
    50844    ORG011338912

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2015 CVS/pharmacy
    CVS.com®   1-800-SHOP CVS

    V-11112
    CVS® Quality
    Money Back Guarantee

    Aspirin 44-389

    Aspirin 44-389

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  • INGREDIENTS AND APPEARANCE
    GENUINE ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-389
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code 44;389
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-389-12 1 in 1 CARTON 05/17/2001 07/08/2019
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/17/2001 07/08/2019
    Labeler - CVS Pharmacy (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(59779-389)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(59779-389)
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