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Aspirin by New World Imports, Inc

Dosage form: tablet, chewable
Ingredients: Aspirin 81mg
Labeler: New World Imports, Inc
NDC Code: 51824-164

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 and pains or as recommended by your doctor.  To reduce fever.

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 chance 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

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 unless directed by a doctor.

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

-You have asthma

Ask a doctor of pharmacist before use if you are taking a prescription drug for 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 10 days

-Ringing in the ears or loss of hearing occurs

-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.

Drink a full glass of water with each dose.

Adults and cildren 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: consult a doctor

saccharin sodium, starch, dextrates, FD and C red #40, flavor

Label

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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 RED NO. 40 
Saccharin Sodium 
Starch, Corn 
Product Characteristics
Colororange (Pale Orange) Scoreno score
ShapeROUND (Round) Size8mm
FlavorImprint CodeAZ;013
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-164-3636 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/31/201108/01/2019
Labeler - New World Imports, Inc (075372276)

 
New World Imports, Inc

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Medically reviewed on Aug 8, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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