FDA Label for Adult Low Dose Aspirin
View Indications, Usage & Precautions
Adult Low Dose Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Aidarex Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet):
Aspirin 81mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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.