Label: UNCOATED ASPIRIN- aspirin tablet

  • NDC Code(s): 59779-249-16, 59779-249-32
  • Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
  • 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 09/15

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  • Active ingredient

    Aspirin 325 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    provides temporary relief of

    • headache
    • pain and fever of colds
    • muscle pain
    • toothache
    • minor pain of arthritis
    • menstrual pain
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  • Warnings

    Reye's syndrome: Children and teenagers who have or 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:

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

    Stomach bleeding warning: This product 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 more or for a longer time than directed
    • 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

    Do not use

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

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking a prescription drug for diabetes, gout or 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.
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms occur
    • fever gets worse or lasts more than 3 days
    • 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 (1-800-222-1222) right away.

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  • Directions

    • drink a full glass of water with each dose
    • adults: 1 to 2 tablets with water.  Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours.
    • children under 12: consult a doctor
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  • Other information

    • store at room temperature
    • use by expiration date on package
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  • Inactive ingredients

    starch

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  • Questions or comments?

    1-800-426-9391 Close
  • Principal Display Panel

    CVS®
    pharmacy

    Uncoated
    ASPIRIN
    TABLETS

    Pain reliever
    Fever reducer (NSAID)

    • Caffeine free
    • Sodium free

    120 TABLETS, 325 mg

    50844   REV1011F24932

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2011 CVS/pharmacy
    www.cvs.com   1-800-shop-CVS

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

    CVS 44-249

    CVS 44-249

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  • INGREDIENTS AND APPEARANCE
    UNCOATED ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-249
    Route of Administration ORAL DEA Schedule     
    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)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;249
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-249-32 1 in 1 CARTON
    1 120 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:59779-249-16 1000 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 08/04/1993
    Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(59779-249)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(59779-249)
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