FDA Label for Aspirin 81mg
View Indications, Usage & Precautions
Aspirin 81mg Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals Inc.. 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.
Otc - Active Ingredient
Aspirin 81mg (NSAID)
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrytalline cellulose, silicon dioxide, stearic acid, talc, titanium dioxide, triethyl citrate
Dosage & Administration
* drink a full glass of water with each dose SEE OVERDOSE WARNING.
adults and children 12 years of age 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 of age | ask a doctor |
Indications & Usage
* for the temporary relief of 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.
Warnings
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:
- 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 everyday while using this product
- Take more or for a longer time than directed.
- 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.
- 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
- 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 last more than 10 days
- Redness or swelling is present
- Fever gets worse or last more than 3 days
- New symptoms occur
- Ringing in the ears or loss of hearing occurs
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do not use
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, 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.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.
Otc - Purpose
Pain reliever
Other Safety Information
* store at room temperature 20 - 25°C (68 - 77°F).
* avoid excessive heat, cold and humidity.
* close cap tightly after use.
Package Label.Principal Display Panel
* Please review the disclaimer below.