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CHILDRENS CHEWABLE ASPIRIN - aspirin tablet, chewable 
Cardinal Health

Drug Facts

Active ingredient

Aspirin 81 mg

Purpose

Analgesic/Antipyretic

Keep Out of Reach of Children

Keep out of the reach of children.

Uses

Temporary relief of minor aches, pains and headaches and to reduce fever associated with colds, sore throats and teething.

Warnings

This package is intended for institutional use only. In case of accidental overdose, contact a Poison Control Center Immediately.

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.

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.

Alcohol Warning: If you consume 3 or more alcoholic drinks everyday, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.

Aspirin may cause stomach bleeding.

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use if you are allergic to aspirin or other pain relievers/fever reducers or for at least 7 days after tonsillectomy or oral surgery.

Directions

To be administered only under adult supervision, repeat every 4 hours, while symptoms persist, up to a maximum of five doses in 24 hours or as directed by a doctor.

Drink water with each dose.

Children under 3 years: Consult a doctor.

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

Ask a doctor before use if you have asthma, stomach problems (such as heartburn, upset stomach or stomach pain) that persist or recur, ulcers, bleeding problems or a child experiencing arthritis pain.

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away if new symptoms occur, redness or swelling is present. If ringing in the ears or loss of hearing occurs, if pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children) or if fever gets worse or lasts for more than 3 days.

Inactive ingredients

flavor, FD&C Yellow #6, saccharin sodium, silicon dioxide, starch, stearic acid, sucrose

Storage

Store at Room Temperature

SKY

MFG. BY: A&Z Pharmaceutical Inc. Hauppauge, NY 11788

Dist. BY: McKesson Packaging Services a business unit of McKesson Corporation

7101 Weddington Rd.

Concord, NC 28027

Health A&Z® Children's Aspirin is not manufactured or distributed by Bayer Consumer Care, distributor of Bayer®

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Children's Chewable Aspirin Orange

81 mg

10 Tablets

Bag Label

CHILDRENS CHEWABLE ASPIRIN 
aspirin  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55154-1473 (63739-434)
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  
SILICON DIOXIDE  
STARCH, CORN  
STEARIC ACID  
SUCROSE  
Product Characteristics
Color PINK (Peach) Score no score
Shape ROUND Size 7mm
Flavor ORANGE Imprint Code AZ;013
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55154-1473-0 10 BLISTER PACK In 1 BAG contains a BLISTER PACK
1 1 TABLET In 1 BLISTER PACK This package is contained within the BAG (55154-1473-0)

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

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