LOW DOSE ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]

LOW DOSE ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]
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NDC 49483-328-01, 49483-328-10
Set ID 55d645bb-8645-4984-a7b9-3e6eed8c6412
Category HUMAN OTC DRUG LABEL
Packager Time-Cap Labs, Inc
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

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

    *nonsteroidal anti-inflammatory drug

  • INACTIVE INGREDIENT

    ANHYDROUS LACTOSE, CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, FD&C YELLOW#6 ALUMINUM LAKE, FD&C RED #40 ALUMINUM LAKE, IRON OXIDE OCHRE, METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, SIMETHICONE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, TALC, TRIETHYL CITRATE

  • PURPOSE

    PURPOSE: PAIN RELIEVER

  • 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

    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
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

  • DO NOT USE

    Do not use

    • if you 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, 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

  • 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

    • 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
    • ringing in the ears or a loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    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

    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

  • STORAGE AND HANDLING

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

    IMAGE OF BOTTLE LABEL
  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN  ENTERIC SAFETY COATED
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Colorwhite (ENTERIC COATED PEACH) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code emobssed;upper;heart;lower;plain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-328-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-328-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34308/11/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-328)

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