Aspirin
FDA Label NDC 52204-103

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 52204-103). 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*) .............................. 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.