Label: ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable

  • NDC Code(s): 49483-334-00, 49483-334-63
  • 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 May 21, 2012

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

  • ACTIVE INGREDIENTS

    Drug Facts
    Active ingredient (in each tablet) Purpose
    Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
    *nonsteroidal anti-inflammatory drug

    Close
  • 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.

    Close
  • INACTIVE INGREDIENT

    Inactive ingredients: bht, dextrates, FD-C yellow #6 aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid

    Close
  • PURPOSE

    PURPOSE:  Pain reliever

    Close
  • 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

    Close
  • 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

    Close
  • 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 serous Illinois. 

    Allergy alert:  Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, 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 nonprescription NSAIDS(aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, tae more or for a longer time than directed..

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE CHEWABLE
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-334
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    aspirin (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) aspirin 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    ORANGE (UNII: 5EVU04N5QU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code UPPER;tcl334;LOWER;PLAIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-334-63 36 in 1 BOTTLE, PLASTIC
    2 NDC:49483-334-00 100000 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/16/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    Time-Cap Labs, Inc 037052099 manufacture
    Close