CHILDRENS IBUPROFEN- ibuprofen suspension 
Cardinal Health 107, LLC
Reference Label Set Id: 1984374e-7639-4a4f-bf96-a614e663e0c4

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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)

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

Warnings

Allergy alert

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

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

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

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 ibuprofen or 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, kidney disease, or had a stroke
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

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
child has symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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 well before using
mL = milliliter
find right dose on chart. If possible, use weight to dose; otherwise use age.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day
Dosing Chart
Weight (lb)Age (yr)Dose (mL)*
*
or as directed by a doctor

under 24 lbs

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 mL

Other information

each 5 mL contains: sodium 2 mg
store at 20-25°C (68-77°F)
do not freeze

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

Questions or comments?

1-800-397-9228

How Supplied

Overbagged with 5 x 5 mL unit dose cups per bag, NDC 55154-1577-5

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L3724771223

LI587 Rev. 06/23

Principal Display Panel

Children’s Ibuprofen Oral Suspension

100 mg/ 5 mL

5 Unit Dose Cups

Bag Label
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1577(NDC:68094-494)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
butylparaben (UNII: 3QPI1U3FV8)  
corn syrup (UNII: 9G5L16BK6N)  
D&C red NO. 33 (UNII: 9DBA0SBB0L)  
FD&C yellow NO. 6 (UNII: H77VEI93A8)  
glycerin (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
propylene glycol (UNII: 6DC9Q167V3)  
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:55154-1577-55 in 1 BAG04/13/2004
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493704/13/2004
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2024
Document Id: cf04f602-e6cc-4cc4-9539-e23c2ca48009
Set id: 9291857c-30b3-414b-99e1-9c127e72c0d4
Version: 8
Effective Time: 20240119
 
Cardinal Health 107, LLC