Otc - Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Invahealth Inc for the product Aspirin (NDC 73376-001). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, 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
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:
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
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
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.
exceed 48 tablets in 24 hours unless directed by a doctor
Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST
microcrystalline cellulose, colloidal silicon dioxide,
croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
acid copolymer, talcum, titanium dioxide, triethyl citrate.
for the temporary relief of minor aches and pains 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.
ask your doctor about other uses for Safety Coated 81 mg Aspirin
In case of overdose, get medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.