Label: LOW DOSE ASPIRIN- aspirin tablet, coated

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

Drug Label Information

Updated December 1, 2023

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

  • DRUG FACTS

  • Active ingredient (in each tablet)

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Reliever

  • 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.

  • 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 enteric-coated 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, shock, asthma(wheezing).

    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 bleeding problems

    Take a blood thinning (anticoagulant) or steroid drug

    Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

  • Directions

    Drink a full glass of water with each dose

    Adults and children of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

    Children under 12 years: consult a doctor

  • Inactive Ingredients

    Anhydrous lactose, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

  • Package/Label Principal Display Panel

    71205-112-30
  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-112(NDC:49483-481)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code HEART
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-112-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
    2NDC:71205-112-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
    3NDC:71205-112-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
    4NDC:71205-112-72120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/19/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-112) , RELABEL(71205-112)