Active Ingredient (In Each Tablet)
Aspirin 325 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product Aspirin (NDC 80425-0293). 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), otc - purpose, indications & usage, warnings, dosage & administration, directions, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 325 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever
temporarily relieves minor aches and pains due to:
headache
muscle pain
toothache
menstrual pain
colds
minor pains of arthritis
temporarily reduces fever
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:
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
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 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.
Directions
• drink a full glass of water with each dose
• adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,
polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.
Manufacturer: 1-800-540-3765
Other information
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package
Stop use and ask a doctor if
* Please review the disclaimer below.