Label: ASPIRIN 81 MG- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 25, 2024

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflamatory drug

  • Purpose

    Pain reliever

  • Uses

    temporarily relieves minor aches and pains

    Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

    ask your doctor about other uses for enteric-coated 81 mg Aspirin

  • Warnings

    Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.

  • OTHER SAFETY INFORMATION

    Allergy Alert: Aspirin may cause a severe allergic reaction which may include:

    - hives

    - facial swelling

    - shock

    - asthma (wheezing)

  • SPL UNCLASSIFIED SECTION

    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 steriod drug

    - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)

    - have 3 or more alcoholic drinks every day while using this product

    - take more or for longer time than directed

  • DO NOT USE

    Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    - taking a prescription drug for diabetes, gout, or arthritis

    - taking any other drug

    - under a doctor's care for any serious condition

  • STOP USE

    Stop use and ask a doctor if

    - an allergic reaction occurs. Seek medical help right away.

    - you are experierance 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

    - 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.

    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 becwause 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 right away.

  • 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 not to exceed 48 tablets in 24 hours unless directed by a doctor

    - children under 12 years: consult a doctor

  • Other information

    - store at 25°C (77°F) excursions premitted between 15°-30°C (59°-86°F)

    - Use by expiration date on package

  • Inactive ingredients

    corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10

  • ASK DOCTOR

    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

    you have not been drinking fluids

    you have lost a lot of fluid due to vomiting or diarrhea

  • Drug Facts

  • HOW SUPPLIED

    NDC: 71335-1774-8: 15 Tablets in a BOTTLE

    NDC: 71335-1774-1: 120 Tablets in a BOTTLE

    NDC: 71335-1774-2: 30 Tablets in a BOTTLE

    NDC: 71335-1774-3: 100 Tablets in a BOTTLE

    NDC: 71335-1774-4: 20 Tablets in a BOTTLE

    NDC: 71335-1774-5: 90 Tablets in a BOTTLE

    NDC: 71335-1774-6: 60 Tablets in a BOTTLE

    NDC: 71335-1774-7: 36 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Aspirin 81 mg EC Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 81 MG 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1774(NDC:69618-066)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code 17;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1774-815 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    2NDC:71335-1774-1120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    3NDC:71335-1774-230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    4NDC:71335-1774-3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    5NDC:71335-1774-420 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    6NDC:71335-1774-590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    7NDC:71335-1774-660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    8NDC:71335-1774-736 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/01/2020
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1774) , RELABEL(71335-1774)