Label: ASPIRIN 81MG tablet

  • 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 April 12, 2022

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

  • ACTIVE INGREDIENT

    Aspirin 81mg (NSAID)

  • INACTIVE INGREDIENT

    colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrytalline cellulose, silicon dioxide, stearic acid, talc, titanium dioxide, triethyl citrate

  • DOSAGE & ADMINISTRATION

    * drink a full glass of water with each dose SEE OVERDOSE WARNING.

    adults and children 12 years of age and overtake 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 ageask a doctor

  • INDICATIONS & USAGE

    * for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

    *ask your doctor about other uses.

  • 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 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 everyday 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.\
    • If you have ever had an allergic reaction to this product or any of its ingredients.

    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

    • 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 last more than 10 days
    • Redness or swelling is present
    • Fever gets worse or last more than 3 days
    • New symptoms occur
    • 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.

    OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

  • PURPOSE

    Pain reliever

  • OTHER SAFETY INFORMATION

    * store at room temperature 20 - 25°C (68 - 77°F).

    * avoid excessive heat, cold and humidity.

    * close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    aspirin

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81MG 
    aspirin 81mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-158-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/18/2020
    Labeler - Strive Pharmaceuticals Inc. (080028013)