CHILDRENS IBUPROFEN- ibuprofen suspension

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each 5 mL)

Ibuprofen USP 100 mg (NSAID) *

*nonsteroidal anti-inflammatory drug
Purpose

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
- take 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

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

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.
use only enclosed dosing cup. Do not use any other dosing device.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day
replace original bottle cap to maintain child resistance

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
- each 5 mL contains:sodium 2 mg
- store between 20-25°C (68-77°F)
- do not use if carton is open, or if carton tape or the tamper-evident ring of cap is broken or missing
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
SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72888-479
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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
Color	white (Off-white)	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72888-479-01	1 in 1 CARTON	03/05/2026
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA220239	03/05/2026

Labeler - Advagen Pharma Ltd. (051627256)

Name	Address	ID/FEI	Business Operations
Establishment
Rubicon Research Limited		737796233	manufacture(72888-479) , analysis(72888-479) , pack(72888-479) , label(72888-479)

CHILDRENS IBUPROFEN- ibuprofen suspension

CHILDRENS IBUPROFEN by

Drug Labeling and Warnings

Drug Details [pdf]