Label: PAIN RELIEVER- aspirin tablet, coated

  • NDC Code(s): 68210-4177-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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, fever or other symptoms needing immediate relief. • ask your doctor about other uses for Aspirin 81 mg

  • 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 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 non-prescription 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 you

    • 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 • fever gets worse or lasts more than 3 days • have stomach pain that does not get better • pain gets worse or lasts more than 10 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.

  • 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 & children 12 years & 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 consult a doctor

  • Other information

    • store at room temperature • avoid excessive heat above 40°C (104°F)

  • Inactive ingredients

    Acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Pouch

    Pain Reliever 81 mg

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4177
    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)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4177-1120 in 1 POUCH; Type 0: Not a Combination Product11/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/22/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)