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NDC 58602-0200-24 CHILDRENS IBUPROFEN 100 mg/5mL Details

CHILDRENS IBUPROFEN 100 mg/5mL

CHILDRENS IBUPROFEN is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is IBUPROFEN.

MedlinePlus Drug Summary

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 58602-0200-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	58602-0200
Product ID	58602-200_a5e55642-8e21-4274-98b2-a49637fadbf8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CHILDRENS IBUPROFEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ibuprofen
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/5mL
Substance Name	IBUPROFEN
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209179
Listing Certified Through	n/a

Package

Package Images

NDC 58602-0200-24 (58602020024)

Pricing Information	N/A
NDC Package Code	58602-200-24
Billing NDC	58602020024
Package	1 BOTTLE in 1 CARTON (58602-200-24) / 120 mL in 1 BOTTLE
Marketing Start Date	2018-04-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d506fcb1-27e0-4495-b166-1eb6ed8dfa09 Details

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen USP 100 mg (NSAID)*

Purpose

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

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.

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 to 8 hours
do not use more than 4 times a day
replace original bottle cap to maintain child resistance
wash dosage cup after each use

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

each 5 mL contains: sodium 2 mg
store between 20 to 25°C (68 to 77°F)
do not use if carton is opened or seal under cap opening is broken or missing
see bottom panel for lot number and expiration date

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) Carton Label

NDC 58602-200-24

#Compare to the active ingredient

in Children's Motrin®

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

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN

ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-200
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)
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
Color	ORANGE (Light orange to orange)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58602-200-24	1 in 1 CARTON	04/17/2018	09/30/2023
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC:58602-200-20	1 in 1 CARTON	04/17/2018	05/20/2022
2		240 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	ANDA209179	04/17/2018	09/30/2023

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-200) , MANUFACTURE(58602-200)

Revised: 5/2022

Document Id: a5e55642-8e21-4274-98b2-a49637fadbf8

Set id: d506fcb1-27e0-4495-b166-1eb6ed8dfa09

Version: 5

Effective Time: 20220520