Fasprin
FDA Label NDC 10597-559

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nobel Laboratories, Llc for the product Fasprin (NDC 10597-559). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings:, otc - do not use, ask doctor before using if you have:, ask a doctor or pharmacist before use if you are taking a prescription drug for:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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 (Fasprin)

Image Of Carton Label (Fasprin)

* Please review the disclaimer below.