Active Ingredient (In Each Tablet)
Aspirin 81 mg (NSAID**)
**nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Aspirin 81mg (NDC 77333-049). 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, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, 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
taking a prescription drug for
•gout •diabetes •arthritis
• an allergic reaction occurs. Seek medical help right away.
• 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 better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or a loss of hearing occurs
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
• drink a full glass of water with each dose
• adults and children 12 years and over:take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
• children under 12 years:consult a doctor
• store at 25 °C (77 °F); excursions permitted between 15°-30°C (59° - 86°F)
dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium, corn starch
* Please review the disclaimer below.