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CHILDRENS ASPIRIN - aspirin tablet, chewable 
Cardinal Helath

Children's Aspirin 81 mg

Drug Information

HOSPAK® UNIT DOSE PRODUCTS

NDC 66553-002-01

CHILDREN'S ASPIRIN (NSAID)

81 mg

ORANGE FLAVORED, CHEWABLE TABLETS

500 COUNT UNIT DOSE TABLETS (50 - 2 x 5 strips)

FOR INSTITUTIONAL USE ONLY

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 allergic 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 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; fells 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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 dose.

Age (yrs) Under 3 3 to under 4 4 to under 6 6 to under 9 9 to under 11 11 to under 12 Adults and children 12 years and over
Weight (lbs) Under 32 32 to 35 36 to 45 46 to 65 66 to 76 77 to 83
Dosage Consult a doctor 2 tablets 3 tablets 4 tablets 4 to 5 tablets 4 to 6 tablets 5 to 8 tablets

Inactive ingredients

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

Storage

Store at room temperature. Do not use if packet is torn, cut or opened. You may report serious side effects to 1-888-952-0050

Mfg. by: A&Z Pharmaceutical, Inc., Hauppauge, NY 11788

Dist. By: Hospak® Unit Dose Products, Rockford, IL 61114

Rev. 03/10

Principal Display Panel

Children's Aspirin (NSAID) 81 MG

10 Flavored Chewable Tablets

Bag

CHILDRENS ASPIRIN 
aspirin  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55154-6752 (66553-002)
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
DEXTRATES  
FD&C YELLOW NO. 6  
SACCHARIN SODIUM  
STARCH, CORN  
Product Characteristics
Color PINK (Peach) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code AZ;013
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55154-6752-0 10 BLISTER PACK In 1 BAG contains a BLISTER PACK
1 1 TABLET In 1 BLISTER PACK This package is contained within the BAG (55154-6752-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/02/2011

Labeler - Cardinal Helath (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK
Revised: 06/2011Cardinal Helath