Active Ingredient(S)
Aspirin 81mg (NSAID)*
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Aspirin 81mg Enteric Coated (NDC 69168-405). 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 81mg (NSAID)*
Pain reliever
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:
Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you:
you are taking a prescription drug for
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 (1-800-222-1222) right away
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow
#10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,
simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
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* Please review the disclaimer below.