ASPIRIN  - aspirin tablet, chewable 
New World Imports, Inc

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Drug Facts

Aspirin 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

Image of Bottle


ASPIRIN 
aspirin   tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)51824-164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
Dextrates 
FD&C Yellow No. 6 
Saccharin Sodium 
Starch, Corn 
Product Characteristics
Colororange (Pale Orange) Score no score
ShapeROUND (Round) Size8mm
FlavorImprint Code AZ;013
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151824-164-3636 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/14/2010

Labeler - New World Imports, Inc (075372276)
Revised: 10/2010New World Imports, Inc