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 Advance Pharmaceutical Inc. for the product Aspirin (NDC 17714-009). 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, use, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each tablet)
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 signs 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 your child
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if the child is
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
| Weight (lbs.) | Age (years) | Dose |
| 77 – 83 | 11 to under 12 | 4 – 6 tablets |
| 66 – 76 | 9 to under 11 | 4 - 5 tablets |
| 46 – 65 | 6 to under 9 | 4 tablets |
| 36 – 45 | 4 to under 6 | 3 tablets |
| 32 – 35 | 3 to under 4 | 2 tablets |
| under 32 | under 3 | ask a doctor |
DRINK A FULL GLASS OF WATER WITH EACH DOSE
corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar
Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
* Please review the disclaimer below.