ASPIRIN 81 MG LOW DOSE- aspirin tablet, coated
VITANE PHARMACEUTICALS, INC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Aspirin 81 mg -Low Dose Safety Coated
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
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 ulcer 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
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 a doctor or pharmacist before use if you are
taking a prescription drug for
◾ gout
◾ diabetes
◾ 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:
◾ feel faint
◾ vomit blood
◾ have bloody or black stools
◾ have stomach pain that does not get better
◾ pain gets worse or lasts more than 10 days
◾ redness or swelling is present
◾ fever lasts more than 3 days
◾ new symptoms occur
◾ ringing in the ears or a loss of hearing occurs
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 25ºC excursions permitted between 15º-30ºC
◾ Use by expiration date on package
Other Ingredients:
Microcrystalline Cellulose, Croscarmellose sodium, Methacrylic acid copolymer, Titanium dioxide, Talcum, Stearic acid, Colloidal silicon dioxide, Triethyl citrate, D&C Yellow #10, FD&C Yellow #6.
Questions or comments?
Call 1-845-267-6700
Monday through Friday, 8 am to 5 pm EST or
www.vitanepharma.com
NDC 60577-005-01
Vitane's Aspirin 81 mg
Pain Reliever (NSAID)*
Low Dose Safety Coated | Aspirin Regimen**
60 Enteric Coated Tablets
**Talk to your doctor or other healthcare provider before using this product for your heart.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
MADE IN USA
Manufactured By:
Vitane Pharmaceuticals, Inc.
125 Wells Avenue
Congers, NY 10920 USA
www.vitanepharma
| ASPIRIN 81 MG
LOW DOSE
aspirin tablet, coated |
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| Labeler - VITANE PHARMACEUTICALS, INC (029029638) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| VITANE PHARMACEUTICALS, INC. | 029029638 | manufacture(60577-005) , pack(60577-005) , label(60577-005) | |