CHILDRENS IBUPROFEN - ibuprofen suspension 
Aurohealth LLC

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Drug Facts

Active ingredient (in each 5 mL)


Ibuprofen USP 100 mg (NSAID)*

Purpose

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

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
* or as directed by a doctor
Weight (lb)
Age (year)
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

Other information

Inactive ingredients

Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum

Questions or comments?
Call 1-855-274-4122


Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label

NDC 58602-200-24
For Ages 2 to 11 Years
Children’s
Ibuprofen
Oral Suspension USP
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Berry Flavor
4 FL OZ (120 mL)
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label

NDC 58602-200-24
For Ages 2 to 11 Years
Children’s
Ibuprofen
Oral Suspension USP
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Berry Flavor
4 FL OZ (120 mL)
AUROHEALTH


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (120 mL) Carton Label

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-200
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)  
RASPBERRY (UNII: 4N14V5R27W)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, POTATO (UNII: 8I089SAH3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGE (Light orange to orange) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-200-241 in 1 CARTON04/17/2018
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:58602-200-201 in 1 CARTON04/17/2018
2240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20917904/17/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-200) , MANUFACTURE(58602-200)

Revised: 12/2019
Document Id: fb58bfb7-de3c-4fef-ba66-d9af2489263b
Set id: d506fcb1-27e0-4495-b166-1eb6ed8dfa09
Version: 3
Effective Time: 20191203
 
Aurohealth LLC