ASPIRIN- aspirin tablet
NCS HealthCare of KY, Inc dba Vangard Labs
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 EC 81 mg
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.
Uses
-temporarily relieves minor aches and pains
-for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
Warnings
Reye's Syndrome
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
Alergy Alert: Aspirin may cause a severe allergic reaction which may include: Hives, facial swelling, asthma (wheezing), shock.
Stomach Bleeding Warning
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.
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.
Ask a doctor or pharmacist before use if you are
taking a prescription drug for gout, diabetes, or arthritis. under a doctor's care for any serious condition, taking any other drug.
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding: feel faint, have a bloody or black stools, vomit blood, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symproms appear, riinging 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.
Inactive ingredients
anhydrous lactose, camauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow #10 aluminum lake, iron oxide ochre, methacryllic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethylcitrate.
Other information
store at 25ºC (77ºF) excursions permitted between 15º-30ºC (59º-86ºF)
use by expiration date on package
**Compare to the active ingredient in BAYER® Low Dose
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose.
Distributed by
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA
| ASPIRIN
aspirin tablet |
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| Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| NCS HealthCare of KY, Inc dba Vangard Labs | 050052943 | RELABEL(0615-3568), REPACK(0615-3568) | |