Label: LOW DOSE ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 70000-0202-2, 70000-0202-3
  • Packager: CARDINAL HEALTH
  • 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 February 1, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Purpose

    Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . .Pain reliever

    *nonsteroidal anti-inflammatory drug

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  • INACTIVE INGREDIENT

    anhydrous lactose,

    carnauba wax, colloidal silicon dioxide,

    croscarmellose sodium, D&C yellow #10

    aluminum 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

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  • 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

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  • 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.

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  • 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

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  • PURPOSE

    Pain reliever

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  • 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 (1-800-222-1222) right away.

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  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0202
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70000-0202-2 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/02/2017
    2 NDC:70000-0202-3 300 in 1 PACKAGE; Type 0: Not a Combination Product 01/18/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/06/2017
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABORATORIES, INC 037052099 manufacture(70000-0202)
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