Label: ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 49483-011-00, 49483-011-01, 49483-011-10
  • Packager: TIME CAP LABS INC
  • 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 April 2, 2014

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

  • ACTIVE INGREDIENTS


    Each tablet contains Aspirin 325 mg (NSAID)

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  • INACTIVE INGREDIENTS

    Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

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  • PURPOSE

    Pain Reliever

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  • DOSAGE AND ADMINISTRATION

    Drink a full glass of water with each doses

    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.

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  • INDICATIONS AND USAGE

    For the temporary relief of aches and pains due to:

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

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  • WARNINGS

    Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)

    Stomach bleeding warning:  This produc tcontains 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.

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  • KEEP OUT OF THE REACH OF CHILDREN

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

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-011
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TCL011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-011-10 1000 in 1 BOTTLE, PLASTIC
    2 NDC:49483-011-01 100 in 1 BOTTLE, PLASTIC
    3 NDC:49483-011-00 100000 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/02/2014
    Labeler - TIME CAP LABS INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABS INC 037052099 manufacture(49483-011)
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