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  5. Label Information: Aspirin

FDA Label for Aspirin

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. DIRECTIONS:
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS

Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Cispharma, Inc. 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.

Drug Facts



Active ingredient (in each tablet)

Aspirin (NSAID*) .............................. 81 mg

*Nonsteroidal anti-inflammatory drug


Uses



For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.


Warnings



Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • facial swelling
  • asthma (wheezing)
  • shock
  • hives

    • 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.


Directions:



  • drink a full glass of water with each dose.
  • adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by doctor.
  • Children under 12 years: consult a doctor

Other Information



  • Store at room temperature

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate


* Please review the disclaimer below.