Label: ASPIRIN ADULT LOW STRENGTH- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

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 November 14, 2012

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti- inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    •  temporarily relieves minor aches and pains
    • other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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:

    • anticoagulation (thinning of the blood)
    • gout
    • diabetes
    • 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
    • allergic reaction occurs
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • any new symptoms appear
    • redness or swelling is present in the painful area

    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. 

  • Directions

    • do not exceed recommended dosage
    • drink a full glass of water with each dose
    • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor
    • children under 12 years of age: consult a doctor
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron
    oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate. *May also contain.

  • Questions or comments?

    Call toll free 1-877-753-3935

  • Principal Display Panel

    Compare to the active ingredient in ASPIRIN REGIMEN BAYER® 81 mg**

    SEE NEW WARNINGS INFORMATION

    Low Dose 81 mg

    ASPIRIN

    adult low strength

    Pain reliever (NSAID)*

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    **This product is not manufactured or distributedby Bayer Corporation Consumer care division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg

  • Product Label

    Valu merchandisers Best Choice

    Enteric coated Aspirin 81 mg

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  ADULT LOW STRENGTH
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-440
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code E;HEART;81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-440-121 in 1 CARTON
    1120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34307/26/2010
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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