Childrens Aspirin

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: Cardinal Helath
NDC Code: 55154-6752

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.

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 33 to under 44 to under 66 to under 99 to under 1111 to under 12Adults and children 12 years and over
Weight (lbs)Under 3232 to 3536 to 4546 to 6566 to 7677 to 83
DosageConsult a doctor2 tablets3 tablets4 tablets4 to 5 tablets4 to 6 tablets5 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

CHILDRENS ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6752(NDC:66553-002)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DEXTRATES 
FD&C YELLOW NO. 6 
SACCHARIN SODIUM 
STARCH, CORN 
Product Characteristics
ColorPINK (Peach) Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeAZ;013
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-6752-010 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 Helath (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 06/2011
 
Cardinal Helath

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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