Label: LOW DOSE ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 71399-8627-1, 71399-8627-2
  • Packager: Akron Phama
  • 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 February 4, 2023

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

  • Drug Facts

    Active Ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    * nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose   Pain reliever

  • INDICATIONS & USAGE

    Uses

    • temporarily relief of minor aches and pains or as recommended by your doctor.  Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief.
  • WARNINGS

    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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert:  Asiprin may cause a severe allergic reaction, which may include:

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

    Stomach bleeding warning:  This product contains an NSAID, which may cause severe stomach bleeding.  Ths 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 of nonprescription NSAIDS [aspirin, ibuprofin, 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 DOCTOR

    Ask a doctor before use if

    • you have asthma
    • 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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • under a doctor's care for any serious condition
    • taking any other drug
  • STOP USE

    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.
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more that 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling present in the painful area
    • new symptoms occur.

    These could be signs of a serious condition.          

  • PREGNANCY OR BREAST FEEDING

    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

    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.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • drink a full glass of water with each dose

    • adults and children 12 years and over:
    • take 4 to 8 tablets every 4 hours while symptoms last
    • do not take more than 48 tablets in 24 hours unless directed by a doctor

    • children under 12 years:  ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 15 º-30 ºC(59 º-86 ºF)
    • read all product information before using
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow#10 al lake, FD&C yellow#6 al lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions or comments?  Call toll-free 1-877-225-6999

    Monday to Friday 9AM to 5PM

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8627
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code A1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8627-11000 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
    2NDC:71399-8627-2120 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/12/2021
    Labeler - Akron Phama (067878881)