ASPIRIN REGULAR STRENGTH- aspirin tablet, coated

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by SMART SENSE (KMART). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves:
      • headache
      • muscle pain
      • toothache
      • menstrual pain
      • pain of colds
      • minor pain of arthritis
    • temporarily reduces fever
  • 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 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:

    • diabetes
    • gout
    • 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 for more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • ringing in the ears or 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).

  • 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
  • Other information

    • store between 20°-25°C (68°-77°F) in a dry place
    • retain carton for complete product information
  • Inactive ingredients

    croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, starch, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Smart Sense™

    Compare to Bayer® Aspirin†

    Aspirin

    Pain Reliever / Fever Reducer (NSAID)

    Regular Strength

    100 Coated Tablets

    325 mg

    image description

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  REGULAR STRENGTH
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49738-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 49738-781-011 in 1 CARTON05/01/2011
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC: 49738-781-031 in 1 CARTON05/01/2011
    2300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC: 49738-781-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/30/2011
    Labeler - SMART SENSE (KMART) (008965873)

  • Trademark Results [ASPIRIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ASPIRIN
    ASPIRIN
    76481358 2788617 Dead/Cancelled
    Simon Carter Accessories, Ltd.
    2003-01-10
    ASPIRIN
    ASPIRIN
    75209895 not registered Dead/Abandoned
    Bayer Aktiengesellschaft
    1996-12-09
    ASPIRIN
    ASPIRIN
    73234351 1171777 Dead/Cancelled
    McIntyre; William A.
    1979-10-09

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