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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
Aspirin Chewable Tablets, 81 mg (NSAID*)

Active ingredient

Compare to Bayer active ingredient

Active ingredient (in each tablet)

Aspirin 81 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of the reach of children.

Uses

Temporary relief of minor aches and pains or as recommended by your doctor – to reduce fever

Warnings

This package is intended for institutional use only. Keep out of reach of children. In case of accidental overdose, get medical help or, 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.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The higher if you – are age 60 or older – have had stomach ulcers or bleeding problems – take a blood thining (anticoagulant) or steroid drug – take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) - have 3 or more alcoholic drinks every day while using this product – take more or for a longer time than directed.

Do not use -if you are allergic to aspirin or any other pain reliever/fever reducer – this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.

Directions

Ask a doctor before use if

– stomach bleeding warning applies to you

– you have a history of stomach problems, such as heartburn

– you have high blood pressure, heart disease, liver cirrhosis or kidney disease

– you are taking a diuretic

– you have asthma

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 -an allergic reaction occurs. Seek medical help right away- 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.

Inactive ingredients

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

Storage

Store at Controlled Room Temperature 15- 30C (59-86F) and in a dry place.

MFG. BY: Allegiant Health. 75 North Industry Ct., 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.

Repackaged by Cardinal Health

Zanesville, OH 43701

L4099107-10316

L4099107-20316

Principal Display Panel

Aspirin Chewable Tablets,

81 mg

10 Tablets

d7a280b7-e61e-4fb9-951c-7fbd260a796cd7a280b7-e61e-4fb9-951c-7fbd260a796c

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: 03/2016
 
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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