Active Ingredient (In Each Tablet):
Aspirin 81mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Adult Low Dose Aspirin
FDA Label NDC 33261-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Adult Low Dose Aspirin (NDC 33261-152). 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, do not use if, 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,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Do Not Use If
You have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
Ask A Doctor Before Use If
- the stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you have asthma
- you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For:
- gout
- diabetes
- arthritis
Stop Use And Ask A Doctor If:
- 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
- allergic reaction occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
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 accidental 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 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hors or as directed by a physician
- children under 12 years: consult a physician
Other Information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- store at room temperature (15°-30°C)
- avoid excess heat and moisture
Questions?
Adverse drug event call: (866) 562-2756
* Please review the disclaimer below.
