Label: ASPIRIN REGULAR STRENGTH- aspirin tablet, coated 

  • Label RSS
  • NDC Code(s): 41520-370-12
  • Packager: Care One (American Sales Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 07/14

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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  • Purpose

    Pain reliever

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • muscle pain
      • toothache
      • menstrual pain\colds
      • minor arthritis pain
    • or as recommended by a doctor
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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 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 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

    • 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 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

    • adults and children 12 years of age or over: take 1 to 2 tablets every 4 hours, while symptoms persist.
    • drink a full glass of water with each dose.
    • do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years of age: do not use
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  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    corn starch, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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  • Principal Display Panel

    Compare to the Active Ingredient in Ecotrin®

    Aspirin Regimen**

    325 mg Regular Strength

    ASPIRIN

    Pain reliever (NSAID)

    Enteric Safety Coated

    Tablets

    †This product is not manufactured or distributed by Prestige Brands, inc., distributor of Ecotrin®.

    **Talk to your doctor before starting aspirin regimen.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

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  • Product label

    Aspirin 325 mg

    Care One Aspirin Tablets

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  REGULAR STRENGTH
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-370
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYSORBATE 80  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    ALUMINUM OXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-370-12 1 in 1 BOX
    1 125 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 08/02/2011
    Labeler - Care One (American Sales Company) (809183973)
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