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Fasprin (Nobel Laboratories, LLC)

Available Formats

Dosage Form Package Information Links
TABLET, ORALLY DISINTEGRATING 100 TABLET, ORALLY DISINTEGRATING in 1 BOX (10597-559-06) Label Information
TABLET, ORALLY DISINTEGRATING 30 TABLET, ORALLY DISINTEGRATING in 1 BOX (10597-559-05) Label Information

Complete Fasprin Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:10597-559
    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
    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
    Color yellow (yellow) Score no score
    Shape ROUND (Round) Size 9mm
    Flavor Imprint Code F
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10597-559-05 30 in 1 BOX
    2 NDC:10597-559-06 100 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 09/20/2006
    Labeler - Nobel Laboratories, LLC (022735189)
    Establishment
    Name Address ID/FEI Business Operations
    Avema Pharma Solutions 804087794 manufacture