Your browser does not support JavaScript! ASPIRIN TABLET [QUALITEST PHARMACEUTICAL, INC.]
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ASPIRIN tablet
[Qualitest Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

■ temporarily relieves minor aches and pains due to the common cold, sore throat, headache, and toothache ■ temporarily reduces fever

WARNINGS

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. If allergy reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an 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 everyday while using this product

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

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 has asthma ■ user takes a diuretic ■ user has not been drinking fluids ■ user has lost a lot of fluids due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ 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 ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children) ■ fever gets worse or lasts for more than 3 days

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 the unborn child or complications during delivery

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ to be administered only under adult supervision ■ if possible use weight to dose, otherwise use age ■ repeat every 4 hours, while symptoms persist, up to a maximum of five doses in 24 hours or as directed by a doctor ■ drink a full glass of water with each does

Age (yrs)Weight (lbs)Dosage
under 3under 32consult a doctor
3 to under 432 to 352 tablets
4 to under 636 to 453 tablets
6 to under 946 to 654 tablets
9 to under 1166 to 764 to 5 tablets
11 to under 1277 to 834 to 6 tablets
Adults and children 12 years and over5 to 8 tablets

Other information

store at room temperature

You may report serious side effects to 1-888-952-0050

Inactive ingredients

Dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

DISPLAY PANEL

Aspirin Enteirc Coated
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C YELLOW NO. 6 
DEXTRATES 
SACCHARIN SODIUM 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AZ013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0024-3636 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/03/2009
Labeler - Qualitest Pharmaceutical, Inc. (011103059)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705manufacture

Revised: 4/2011
 
Qualitest Pharmaceutical, Inc.

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