ASPIRIN
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aspirin tablet, chewable
New World Imports, Inc
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Drug FactsAspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Temporary relief of minor aches, pains and headaches. To reduce fever associated with colds, sore throats, teething.
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 NSAID, which may cause severe stomach bleeding. The change is higher if the user:
-Has had stomach ulcers or bleeding problems
-Takes a blood thinning (anticoagulant) or steroid drug
-Takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
-Takes more or for a longer time than directed
-Is age 60 or older
-Has 3 or more alcoholic drinks every day while using this product
Sore Throat Warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by haver, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use: if you are allergic to aspirin or other pain relievers / fever reducers. For at least 7 days after tonsillectomy or oral surgery.
Ask a doctor before use if:
-Stomach bleeding warning applies to user
-user has history of stomach problems, such as heartburn
-User has high blood pressure, heart disease, liver cirrhosis, or kidney disease
-User is taking a diuretic
-User has not been drinking fluids
-User has lost a lot of fluids due to vomiting or diarrhea
Ask a doctor of pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood), diabetes, gout, or arthritis.
Stop use and ask a doctor if:
-User experiences any of the following signs of stomach bleeding: feels faint, vomits blood, has bloody or black stools, has stomach pain that does not get better
-An allergic reaction occurs. Seek medical help help right away
-New symptoms occur
-Redness or swelling is present
-Pain gets worse or lasts for more than 5 days
-Fever gets worse or lasts for more than 3 days
-You may report side effects to 1-888-952-0050
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 specifically directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.
To be administered only under adult supervision. Report every 4 hours, while symptoms persist, up to maximum of five doses in 24 hours of directed by a doctor. Drink water with each dose. Children under 3 consult a doctor.
Ages 3 to under 4 years (Weight 32 to 35 lbs): Dosage 2 tablets
Ages 4 to under 6 years (Weight 36 to 45 lbs): Dosage 3 tablets
Ages 6 to under 9 years (Weight 46 to 65 lbs): Dosage 4 tablets
Ages 9 to under 11 years (Weight 66 to 76 lbs): Dosage 4 - 5 tablets
Ages 11 to under 12 years (Weight 77 to 83 lbs): Dosage 4 - 6 tablets
Adults and children 12 years or over: 5 to 8 tablets
Flavor, saccharin sodium, silicon dioxide, starch, stearic acid, sucrose, FD and C yellow 6
ASPIRIN
aspirin tablet, chewable |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 09/14/2010 |
Labeler - New World Imports, Inc (075372276) |