Label: ASPIRIN tablet, coated

  • NDC Code(s): 11673-181-12, 11673-181-50
  • Packager: TARGET CORPORATION
  • 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 August 19, 2021

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Aspirin 81 mg (NSAID*)
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain reliever

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains 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

    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 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

    Do not use If youn are allergic to aspirin or any other pain reliever/fever reducer

  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, sucg 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
  • 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 experience 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 to 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. lt 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°(59°-86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide,croscarmellose sodium,D&C yellow no.10, aluminium lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer,microcrystalline cellulose,polysorbate 80,simethicone,sodium hydroxide,sodium lauryl sulfate starch,talc,titanium dioxide,triethyl citrate

  • QUESTIONS

    Questions?Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    481R target Low dose Aspirin-carton label 120ct

    481R target Low Dose aspirin bottle label-120ct

    481R target Low Dose aspirin bottle label-500ct

  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-181
    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)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUND (bi-convex) Size7mm
    FlavorImprint Code HEART;RAISED
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-181-121 in 1 CARTON01/01/2020
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11673-181-50500 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2020
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(11673-181)