Adult Low Dose Aspirin Tablet, Delayed Release
FDA Label NDC 57237-349

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Adult Low Dose Aspirin (NDC 57237-349). 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 do not use if imprinted safety seal under cap is broken or missing., uses, warnings, do not use, keep out of reach of children., directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.

Drug Facts

Active ingredient (in each tablet)                        Purpose
Aspirin 81 mg (NSAID)*..................................Pain reliever
*nonsteroidal anti-inflammatory drug

Uses

  • 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 headache or 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:

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

    • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

    The chance is higher if you: 

    • are age 60 or older 
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug 
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 
    • have 3 or more alcoholic drinks every day while using this product 
    • take more or for a longer time than directed

Do Not Use

  • if you are allergic to aspirin, or any other pain reliever/fever reducer

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: 
  • take 4 to 8 tablets every 4 hours while symptoms last
  • do not take more than 48 tablets in 24 hours unless directed by doctor
  • children under 12 years: ask a doctor

    • Other information

    • store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,
microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate

Package Label.Principal Display Panel

Adult Low Dose
Aspirin
81 mg

NDC 57237-349-12

120 Tablets

Aspirin-label (Aspirin Label)

Aspirin-label (Aspirin Label)

* Please review the disclaimer below.