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 Chewable 81 mg (in each tablet)

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 every day, 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

36 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, 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 Controlled Room Temperature 15- 30C (59-86F).

SKY

MFG. BY: A&Z Pharmaceutical Inc. 75 North Industry Court, Deer Park, NY 11729

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

7101 Weddington Rd.

Concord, NC 28027

Health A2Z Children's Aspirin is not manufactured or distributed by Bayer Consumer Care, distributor of Bayer

Bayer and Health A2Z are trademarks owned by their respective owners.

Compare to Bayer active ingredient*

Repackaged by Cardinal Health

Zanesville, OH 43701

L4099107-10614

L4099107-20614

Principal Display Panel

Aspirin Chewable Tablets,

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 in 1 BAG
11 TABLET, CHEWABLE 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(55154-1473)

Revised: 07/2014
 
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.

Hide
(web2)