DrugCite

ASPIRIN - aspirin tablet 
Qualitest Pharmaceutical, Inc.

Children’s Chewable Aspirin (Orange Flavor)

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 3 under 32 consult a doctor
3 to under 4 32 to 35 2 tablets
4 to under 6 36 to 45 3 tablets
6 to under 9 46 to 65 4 tablets
9 to under 11 66 to 76 4 to 5 tablets
11 to under 12 77 to 83 4 to 6 tablets
Adults and children 12 years and over 5 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 Type HUMAN OTC DRUG NDC Product Code (Source) 0603-0024
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
STARCH, CORN  
FD&C YELLOW NO. 6  
DEXTRATES  
SACCHARIN SODIUM  
Product Characteristics
Color orange Score no score
Shape ROUND Size 8mm
Flavor Imprint Code AZ013
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0603-0024-36 36 TABLET In 1 PACKAGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/03/2009

Labeler - Qualitest Pharmaceutical, Inc. (011103059)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
Name Address ID/FEI Operations
A&Z Pharmaceutical, Inc. 926820705 manufacture
Revised: 04/2011Qualitest Pharmaceutical, Inc.