CHILDRENS IBUPROFEN- ibuprofen suspension 
Advagen Pharma Ltd.

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Children's Ibuprofen

Drug Facts

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:

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:

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 24

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

*or as directed by a doctor

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, glycerine, orange flavor, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments?

Call +1 866-488-0312

Manufactured by:

Rubicon Research Limited,

Satara, 415004 India.


Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

www.advagenpharma.com

Rev. 07/2025

PRINCIPAL DISPLAY PANEL

Children’s Ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL - NDC 72888-479-01 - 120 mL Carton Label

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Children’s Ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL - NDC 72888-479-01 - 120 mL Bottle Label

image description

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72888-479
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)  
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
Colorwhite (Off-white) Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72888-479-011 in 1 CARTON03/05/2026
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA22023903/05/2026
Labeler - Advagen Pharma Ltd. (051627256)
Establishment
NameAddressID/FEIBusiness Operations
Rubicon Research Limited737796233manufacture(72888-479) , analysis(72888-479) , pack(72888-479) , label(72888-479)

Revised: 3/2026
Document Id: 4cd0bf13-9659-1b1c-e063-6394a90a899a
Set id: 4b8b06f3-8557-4645-af27-c0819e163b79
Version: 1
Effective Time: 20260312
 
Advagen Pharma Ltd.