FASPRIN (ASPIRIN) TABLET, ORALLY DISINTEGRATING [NOBEL LABORATORIES, LLC]

FASPRIN (ASPIRIN) TABLET, ORALLY DISINTEGRATING [NOBEL LABORATORIES, LLC]
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NDC 10597-559-05, 10597-559-06
Set ID 73859ea9-01a0-4c3d-97d4-17b9d3378899
Category HUMAN OTC DRUG LABEL
Packager Nobel Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • 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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