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 Vitane 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.
Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains.
- ask your doctor about other uses for enteric-coated 81 mg Aspirin.
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Inactive Ingredient
corn starch, pregelatinized starch, povidone, microcrystalline celulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.
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
- 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 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
Do Not Use Section
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: 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 loss of hearing occurs
these could be signs of a serious condition.
Ask Doctor/Pharmacist Section
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for gout, diabetes, or arthritis
- taking any other medication
- under a doctor’s care for any serious condition
Stop Use Section
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: 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 loss of hearing occurs
these could be signs of a serious condition.
Pregnancy Or Breast Feeding Section
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.
Ask A Doctor Before Use
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
Keep Out Of Reach Of Children Section
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Storage
- store at 25°C (77°F); excursions permitted between 15°and 30°C (59°and 86°F)
- -use by expiration date on package.
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
Principal Display Panel
NDC 60577-807-01
Vitane's
Aspirin 81mg
Pain Reliever -
Aspirin USP 81 mg (NSAID) Enteric Coated
60 tablets
* Please review the disclaimer below.
