Active Ingredient(S)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Aspirin 81mg Enteric Coated (NDC 69168-006). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
for the temporary relief of minor aches and pain or as recommended by your doctor.
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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, facial swelling, asthma (wheezing), shock.
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
If pregnant or breast-feeding, 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
colloidal silicon dioxide, corn starch, crospovidone, D&C yellow #10 aluminum lake,
FD&C yellow #6 aluminum lake,hypromellose, methacrylic acid copolymer,
microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate
* Please review the disclaimer below.