Label: RIGHT REMEDIES ASPIRIN LOW DOSE 81 MG- aspirin 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 December 17, 2021

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

    Pain reliever

  • Uses

    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 for 81 mg Aspirin

  • 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 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

    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 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 lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • redness or swelling is present

    • new symptoms occur

    • ringing in the ears or a 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.

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

    Keep out of reach of children.

  • 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

    do not take more than 48 tablets in 24 hours

     children under 12 years consult a doctor

  • Other information

    store at 20º -25°C (68° - 77°F)
     Avoid excessive heat above 40°C (104°F)

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, fumed silica, methacrylic acid and ethyl acrylate co-polymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

  • Questions or comments?

    call 1-888-577-8033 Monday - Friday 8am - 4pm EST

  • Packaging

    IMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    RIGHT REMEDIES ASPIRIN LOW DOSE 81 MG 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code A1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-161-31300 in 1 BOTTLE; Type 0: Not a Combination Product06/09/2021
    2NDC:70692-161-50500 in 1 BOTTLE; Type 0: Not a Combination Product06/09/2021
    3NDC:70692-161-111000 in 1 BOTTLE; Type 0: Not a Combination Product06/09/2021
    4NDC:70692-161-65365 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/09/2021
    Labeler - Strive Pharmaceuticals Inc (080028013)