IBUPROFEN CHILDRENS- ibuprofen suspension 
Cardinal Health (Leader) 70000

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Ibuprofen Oral Suspension, USP

Active ingredient (in each 5 mL)

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

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?

Dosing Chart

Weight (lb)Age (yr)Dose (mL)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL

* or as directed by a doctor

Other information

Inactive ingredients

acesulfame potassium, citric acid anhydrous, FD&C blue #1, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, artificial raspberry flavor, sucrose, xanthan gum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal display panel

COMPARE TO CHILDREN'S MOTRIN®† active ingredient

See New Warnings

For Ages 2 to 11 years

Children's Ibuprofen

Oral Suspension, USP (NSAID)**

100 mg per 5 mL

Pain Reliever

Fever Reducer

Blue Raspberry Flavor

Shake Well Before Using

Lasts up to 8 hours

Alcohol Free

FL OZ (mL)

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children.

†This product is not affiliated with, manufactured by, or produced by the makers or owners of Children's Motrin®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label

Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug

LEADER Children's Ibuprofen

IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0259
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorRASPBERRY (blue-raspberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0259-11 in 1 CARTON09/15/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491609/15/201712/31/2024
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 1/2023
Document Id: a46485e2-bf7e-436f-89b7-e1566d857709
Set id: aa5baafe-3ebd-47a8-826f-59330e8751e5
Version: 8
Effective Time: 20230112
 
Cardinal Health (Leader) 70000