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Manufacturer:New World Imports, Inc
Category:Over-the-counter (OTC) Marketed Drugs

Drug Facts

ASPIRIN  - aspirin tablet, chewable 
New World Imports, 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.


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 tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-164
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 81 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Yellow No. 6  
Saccharin Sodium  
Starch, Corn  
Product Characteristics
Color orange (Pale Orange) Score no score
Shape ROUND (Round) Size 8mm
Flavor Imprint Code AZ;013
# Item Code Package Description Multilevel Packaging
1 NDC:51824-164-36 36 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE None

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)

Revised: 10/2010 New World Imports, Inc

Reproduced with permission of U.S. National Library of Medicine

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