FDA Label for Aspirin 81 Mg
View Indications, Usage & Precautions
Aspirin 81 Mg Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
Purpose
Pain reliever
Uses
temporarily relieves minor aches and pains
Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for enteric-coated 81 mg Aspirin
Warnings
Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.
Other Safety Information
Allergy Alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
Other
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steriod drug
- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
Otc - Do Not Use
Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
Otc - Stop Use
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you are experierance any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs.
these could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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 becwause it may cause problems in the unborn child or complications during delivery.
Otc - 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.
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 25°C (77°F) excursions premitted between 15°-30°C (59°-86°F)
- Use by expiration date on package
Inactive Ingredients
corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10
Otc - 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
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea
How Supplied
Product: 50090-5476
NDC: 50090-5476-3 90 TABLET, COATED in a BOTTLE
* Please review the disclaimer below.