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Pill Identifier Information of ASA 500 MG Oral Tablet

Drug Information

ASA 500 MG Oral Tablet

Imprint: TCL382
Shape: C48348
Color: C48325
Ingredients: Aspirin
Size: 12.00
Score: 1
Rxtty: SY
Author: Time-Cap Labs, Inc
Inactive Ingredients: MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) / CROSCARMELLOSE SODIUM / HYPROMELLOSES / CELLULOSE, MICROCRYSTALLINE / MINERAL OIL / TITANIUM DIOXIDE>

Complete 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 lost a lot of fluid due to vomiting or diarrhea
    • 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, hypromellose, microcrystalline cellulose,mineral oil, titanium dioxide
  • 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/fever reducer
  • 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 500 mg (NSAID*) *non-steroidal anti-inflammatory drug
  • PRINCIPAL DISPLAY PANEL

    label copy

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  EXTRA STRENGTH
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg  in 500 
    Inactive Ingredients
    Ingredient NameStrength
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code TCL382
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-382-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-382-00100000 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 finalpart34302/11/2013
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-382)