CHILDRENS IBUPROFEN- ibuprofen suspension 
Cardinal Health

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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)1


1
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

Distributed by:

Cardinal Health

Dublin, OH 43017

L49748610318

LI 587
Rev. 04/13

Principal Display Panel

Children’s Ibuprofen Oral Suspension

200 mg/ 10 mL

5 x 10 mL Unit Dose Cups

bag label
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1585(NDC:68094-503)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
FD&C red NO. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1585-510 in 1 BAG09/14/200610/31/2018
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493709/14/200610/31/2018
Labeler - Cardinal Health (603638201)

Revised: 11/2020
 
Cardinal Health