Label: FASPRIN- aspirin tablet, orally disintegrating

  • 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 November 30, 2010

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  • Active Ingredient (In Each Tablet)

    Aspirin 81 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    For temporary relief of minor aches and pains

  • Warnings:

    Reye's syndrome: Children and teenagers should not use this medicine
    for chicken pox or flu symptoms before a doctor is consulted about
    Reye's syndrome, a rare but serious illness reported to be associated
    with aspirin.

    Alcohol Warning:     If you consume 3 or more alcoholic drinks every day, ask
    your doctor whether you should take aspirin or other pain relievers/fever
    reducers. Aspirin may cause stomach bleeding.

    • If you are allergic to aspirin
    • With any other pain reliever/fever reducer
    • If you have ever had an allergic reaction to any other pain reliever/fever reducer
    • For pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
    • With any other product containing aspirin

    Ask doctor before using if you have:

    • Asthma
    • Bleeding problems
    • Stomach problems (such as heartburn, upset stomach or stomach pain) gastric ulcers

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

    • Anticoagulation (thinning of blood)
    • Diabetes
    • Gout
    • Arthritis

    Stop use and ask a doctor if:

    • Ringing in the ears or loss of hearing occurs
    • Pain or fever persists or gets worse
    • New symptoms occur
    • Redness or swelling is present

    If pregnant or breast-feeding baby,

    ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions: Remove tablet from backing by bending at perforation and
    peeling back cover. Place tablet on tongue and allow saliva to dissolve the
    tablet for rapid absorption.
    Adults: Take 1 tablet daily, do not exceed 36 tablets in 24 hours, or as
    directed by a doctor. Children: Consult a doctor.

  • Inactive Ingredients:

    Citric Acid, Crospovidone, D and C Yellow #10, Flavor, Glucosamine Sulfate-K, Mannitol, Sodium Stearyl Fumarate, Sorbitol, Sunnette K, Zinc Gluconate

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Nobel Laboratories, LLC

    3413 Spanish Oak Drive  Austin, TX 787314

    www.NobelLabs.com
  • STORAGE AND HANDLING

    Store Product Below 90 degrees F. Protect from heat, light and moisture.

    U.S Patents 6,596,708 / 6,930,099 and Patents Pending
  • Package Label Section

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FASPRIN 
    aspirin tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10597-559
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    SORBITOL (UNII: 506T60A25R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeROUND (Round) Size9mm
    FlavorImprint Code F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10597-559-0530 in 1 BOX
    2NDC:10597-559-06100 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34309/20/2006
    Labeler - Nobel Laboratories, LLC (022735189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avema Pharma Solutions804087794manufacture
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