Label: ASPIRIN LOW DOSE ENTERIC COATED- aspirin tablet, coated

  • NDC Code(s): 49483-387-00, 49483-387-10, 49483-387-12
  • Packager: Time-Cap Labs, Inc
  • 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 December 17, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient in Each tablet

    Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug
  • 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
  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
  • 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 non prescription 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.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis; under a doctor's care for any serious condition; taking any other drug
  • DO NOT USE

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

  • STOP USE

    Stop use and ask a doctor if: 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 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health profession 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

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

    K

  • 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
  • INACTIVE INGREDIENT

    Inactive ingredients: anhydrous lactose, carnauba 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

  • PURPOSE

    Uses - temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
  • PRINCIPAL DISPLAY PANEL

    BOTTLE LABEL IMAGEEnter section text here

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE ENTERIC COATED
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-387
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    IRON (UNII: E1UOL152H7)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code embossed;upper;heart;lower;plain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-387-12120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-387-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    3NDC:49483-387-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34306/28/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-387)
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