Active Ingredient (In Each Tablet):
Aspirin 81mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Adult Low Dose Aspirin (NDC 50090-0552). 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 (in each tablet):, purpose, indications & usage, warnings, do not use if, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking a prescription drug for:, 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)*
*nonsteroidal anti-inflammatory drug
Pain reliever
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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:hivesasthma (wheezing)facial swellingshockStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get betterallergic reaction occurspain gets worse or lasts more than 10 daysredness or swelling is present any new symptoms occurringing in the ears or loss of hearing occursThese could be signs of a serious condition.
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Adverse drug event call: (866) 562-2756
Product: 50090-0552
NDC: 50090-0552-1 120 TABLET, DELAYED RELEASE in a BOTTLE
NDC: 50090-0552-2 30 TABLET, DELAYED RELEASE in a BOTTLE
NDC: 50090-0552-3 90 TABLET, DELAYED RELEASE in a BOTTLE
* Please review the disclaimer below.