Active Ingredient
Active ingredient (in each tablet)
Aspirin325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Aspirin (NDC 84269-2501). 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, purpose, indications & usage, warnings, other, stomach bleeding warning:, do not use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
Aspirin325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves
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:
If an allergic reaction occurs, stop use and seek medical help right away.
Adults and children: (12 years and over) Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
Children under 12 years: Consult a doctor
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer
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
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycol
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