Label: ASPIRIN LOW DOSE- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 29, 2023

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

  • 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
    • ask your doctor about other uses for 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 your are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
    • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis

    Stop use and ask a doctor if

    • 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
    • an allergic reaction occurs. Seek medical help right away
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs

    These can be signs of a serious condition.

    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.

  • Directions

    • drink a full glass of water with each dose
    • swallow whole, do not chew or crush
    • do not exceed recommended dose
    • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • store at 20-25°C (68-77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
  • Inactive ingredients

    cellulose,D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, PEG, polydextrose, silica, simethicone, sodium
    bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate, wax.

  • Questions or comments?

    1-800-540-3765

  • HOW SUPPLIED

    NDC: 71335-0622-8: 15 Tablets in a BOTTLE

    NDC: 71335-0622-1: 120 Tablets in a BOTTLE

    NDC: 71335-0622-2: 30 Tablets in a BOTTLE

    NDC: 71335-0622-3: 100 Tablets in a BOTTLE

    NDC: 71335-0622-4: 20 Tablets in a BOTTLE

    NDC: 71335-0622-5: 90 Tablets in a BOTTLE

    NDC: 71335-0622-6: 60 Tablets in a BOTTLE

    NDC: 71335-0622-7: 36 Tablets in a BOTTLE

    NDC: 71335-0622-9: 10 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Aspirin 81 mg EC Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0622(NDC:57896-981)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0622-815 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    2NDC:71335-0622-1120 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2018
    3NDC:71335-0622-230 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
    4NDC:71335-0622-3100 in 1 BOTTLE; Type 0: Not a Combination Product07/11/2018
    5NDC:71335-0622-420 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    6NDC:71335-0622-590 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
    7NDC:71335-0622-660 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2018
    8NDC:71335-0622-736 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2018
    9NDC:71335-0622-910 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34307/01/2000
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0622) , RELABEL(71335-0622)