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Enteric Coated Aspirin (Time-Cap Labs, Inc)

Available Formats

Dosage Form Package Information Links
TABLET, DELAYED RELEASE 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00) Label Information
TABLET, DELAYED RELEASE 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-01) Label Information
TABLET, DELAYED RELEASE 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-10) Label Information

Complete Enteric Coated Aspirin Information

  • 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

  • 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 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil,  polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate


  • INDICATIONS & USAGE

    Use for the temporary relief of minor aches and pains due to:

    headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor


  • PURPOSE

    Pain Reliever


  • 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, asthmaaa9wheezing)

    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.


  • ACTIVE INGREDIENT

    In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug


  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED ASPIRIN   REGULAR STRENGTH
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-331
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg  in 325 
    Inactive Ingredients
    Ingredient Name Strength
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code T
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-331-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:49483-331-00 100000 in 1 CARTON
    3 NDC:49483-331-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/04/2011
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time-Cap Labs, Inc 037052099 manufacture(49483-331)