Aspirin
FDA Label NDC 52204-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cispharma, Inc for the product Aspirin (NDC 52204-111). 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 drug facts, uses, warnings, directions:, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) .............................. 325 mg

Uses

For the temporary relief of minor aches and pains due to headache, minor arthritis, colds, muscle pain, toothache, menstrual pain, or as recommended by your doctor

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:

  • Do not take more than directed
  • Adults and children 12 years of age and over: take 1 to 2 tablets every 4 while symptoms persist. Drink a full glass of water with each dose. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • Children under 12 years: consult a doctor

Other Information

  • Store below 25°C

Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow # 6 al lake, hypromellose, methacrylic acid copolymer, starch, talc, titanium dioxide, triacetin, triethyl citrate

* Please review the disclaimer below.