Label: ASPIRIN - aspirin tablet

  • 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 October 23, 2013

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

  • Active Ingredient

    (in each tablet)

    Aspirin 81 mg (NSAID)

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  • Purpose

    Pain Relief

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  • Uses

    • temporarily relieves minor aches and pains
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  • 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
    • Asthma (wheezing)
    • Shock
    • Facial Swelling

      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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
    • have 3 or more alcoholic drinks every day while using this product
    • takes more or for a longer time than directed

      Do not use

    • if you have ever had an allergic reaction to any pain reliever or fever reducer.

      Ask a doctor before use if:

    • The stomach bleeding warning applies to you
    • You have history of stomach problems such as heartburn
    • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • You have asthma
    • You are taking a diuretic

      Ask a doctor or pharmacist before use if you are taking a prescription drug for :

    • Gout
    • Diabetes
    • Arthritis

      Stop use and ask a doctor if

    • you experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • New symptoms occur
    • redness or swelling is present
    • ringing in the ears or a loss of hearing occurs

      These could be signs of serious conditions.

      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.

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  • 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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  • Directions

    Adults and Children 12 years and over:

    For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.

    Children under 12 years of age: Do not use unless directed by a doctor.

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  • Other Information

    • Store at a controlled temperature between 62 and 77 degrees F
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  • Inactive Ingredients

    Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

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  • Questions?

    Call 1-855-314-1850

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: Velocity Pharma LLC

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    5a83ea7c-figure-01

    5a83ea7c-figure-02

    NDC: 76168-009-10 –60 COUNT

    Enteric Coated to help prevent upset stomach

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-009
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    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 A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76168-009-10 60 in 1 BOTTLE
    1 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/01/2011
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)
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