FDA Label for Aspirin Pain Reliver
View Indications, Usage & Precautions
Aspirin Pain Reliver Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, 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
Aspirin 81mg (NSAID)
Purpose
Pain reliever
nonsteroidal anti-inflammatory drug
Uses:
temporarily relieves minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for Bayer Safety Coated 81mg Aspirin
Warnings:
Reye's syndrome
Children and teenagers who have or are recovering from chickenpox 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:
- hives
- facial swelling
- asthma (wheezing)
- shock
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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 if you have ever had an allergic reaction to this product or any of its ingredients
Ask Doctor:
Ask a doctor before use if
- 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 are taking a diuretic
- you have asthma
Ask Doctor/Pharmacist:
taking a prescription drug for:
diabetes
gout
arthritis
Stop Use And Ask A Doctor If
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- pain gets worse or lasts for 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 loss of hearing occurs
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
Pregnancy
sk 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 CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
Other Information
•store at 20°-25°C (68°-77°F)
•close cap tightly after use
•read all product information before using.
Inactive Ingredients
Microcrystalline Cellulose, Silicon dioxide, Talcum, Cross-carmellose sodium, Steric acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, FD&C Yellow#10,FD&C Yellow #6
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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