FDA Label for Fasprin

View Indications, Usage & Precautions

Fasprin Product Label

The following document was submitted to the FDA by the labeler of this product Nobel Laboratories, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 medicinefor chicken pox or flu symptoms before a doctor is consulted aboutReye's syndrome, a rare but serious illness reported to be associatedwith aspirin.Alcohol Warning: If you consume 3 or more alcoholic drinks every day, askyour doctor whether you should take aspirin or other pain relievers/feverreducers. Aspirin may cause stomach bleeding.

Otc - Do Not Use



  • 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.


Otc - 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


Other



Manufactured for: Nobel Laboratories, LLC

3413 Spanish Oak DriveĀ  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




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