Childrens Chewable Aspirin

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: Cardinal Health
NDC Code: 55154-1473

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 432 to 352 tablets
4 to under 635 to 453 tablets
6 to under 946 to 654 tablets
9 to under 1166 to 764-5 tablets
11 to under 1277 to 834-6 tablets
adults and children 12 years and over5-8 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

CHILDRENS CHEWABLE ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1473(NDC:63739-434)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
SACCHARIN SODIUM 
SILICON DIOXIDE 
STARCH, CORN 
STEARIC ACID 
SUCROSE 
Product Characteristics
ColorPINK (Peach) Scoreno score
ShapeROUNDSize7mm
FlavorORANGEImprint CodeAZ;013
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1473-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 06/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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