Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Vitane Pharmaceuticals, Inc for the product Aspirin 81mg (NDC 60577-807). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, inactive ingredient, warnings, allergy alert, other, do not use section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
Pain reliever
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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.
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.
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- shock
- asthma (wheezing)
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
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 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 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.
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 if
stomach bleeding warning applies to you
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).
NDC 60577-807-01
Vitane's
Aspirin 81mg
Pain Reliever -
Aspirin USP 81 mg (NSAID) Enteric Coated
60 tablets
* Please review the disclaimer below.