Label: ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 0536-1004-10, 0536-1004-41
  • Packager: RUGBY LABORATORIES, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 14, 2014

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

  • ACTIVE INGREDIENTS

    EACH TABLET CONTAINS; ASPIRIN 81 MG (nsaid)* NON STEROIDAL ANTI-INFLAMMATORY DRUG

    Close
  • Inactive Ingredients

    anhydrous lactose, carnauba wax, collodidal silicon dioxide, croscarmellose sodium, d&c yellow #10 aluminumlake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, tatanim dioxide, triethyl citrate

    Close
  • 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, consul a doctor

    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 becausse serious side effects may occur.

    Close
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-lie symptoms should not use this product.  When using this product, if changes in behaviour 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, 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.

    Close
  • PURPOSE

    Pain Reliever

    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1004
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code heart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1004-41 120 in 1 BOTTLE, PLASTIC
    2 NDC:0536-1004-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/14/2014
    Labeler - RUGBY LABORATORIES, INC (191427277)
    Registrant - TIME CAP LABS, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABS, INC 037052099 manufacture(0536-1004)
    Close