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Childrens Ibuprofen by Cardinal Health

Dosage form: suspension
Ingredients: Ibuprofen 200mg in 10mL
Labeler: Cardinal Health
NDC Code: 55154-1585

CHILDREN'S IBUPROFEN ORAL SUSPENSION
Berry Flavor

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)


nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/Fever reducer

Uses

temporarily:

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
reduces fever
This product is intended for use in children.

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
blisters
asthma (wheezing)
shock
skin reddening
rash

If an 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 your child:

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

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use
if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has problems or serious side effects from taking pain relievers or fever reducers
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
child has asthma
child is taking a diuretic

Ask a doctor or pharmacist before use if the child is
under a doctor's care for any serious condition
taking any other drug

When using this product
give with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
the child does not get any relief within first day (24 hours) of treatment
fever or pain gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
use as directed per healthcare professional
this product does not contain directions or complete warnings for adult use
do not give more than directed
shake cups well before using
if needed, repeat dose every 6 - 8 hours
do not use more than 4 times a day

Other Information
each teaspoon contains: sodium 2 mg
store at 20-25°C (68-77°F)
do not freeze
See individual label or shipper label for lot number and expiration date.

Inactive Ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Alcohol Free, Gluten Free

How Supplied

Available :

Overbagged with 5 cups (10 mL per unit dose cup) per bag, NDC 55154-1585-5

Manufactured By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L49748610514

LI 587
Rev. 04/13

Principal Display Panel

Children’s Ibuprofen Oral Suspension

200 mg/ 10 mL

5 x 10 mL Unit Dose Cups

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1585(NDC:68094-503)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C yellow NO. 10 
FD&C red NO. 40 
glycerin 
high fructose corn syrup 
HYPROMELLOSE, UNSPECIFIED 
polysorbate 80 
water 
sodium benzoate 
sorbitol 
xanthan gum 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1585-510 CUP, UNIT-DOSE in 1 BAG
110 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493709/14/2006
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-1585)

Revised: 01/2018
 
Cardinal Health

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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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