Children's Ibuprofen Oral Suspension, USP Drug Facts

Manufacturer: A-S Medication Solutions
Effective date: 2025-09-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:13:31

Label at a glance#

Productibuprofen

Active ingredientIBUPROFEN

Label structure10 sections

Indications and uses

temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Dosage and administration

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 below. If possible, use weight to dose; otherwise use age. remove bottle cap and squeeze your child's dose into the dosing cup use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use mo...

Storage and handling

each 5 mL contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-244-9825

Label contents#

Full prescribing information#

Active ingrident

OTC - ACTIVE INGREDIENT SECTION

(in each 5 ml)

Ibuprofen 100 mg (NSAID)^*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

OTC - WHEN USING SECTION

temporarily:

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
reduces fever

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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 below. If possible, use weight to dose; otherwise use age.
remove bottle cap and squeeze your child's dose into the dosing cup
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
*or as directed by a doctor
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

Other information

STORAGE AND HANDLING SECTION

each 5 mL contains:sodium 2 mg
store between 20-25°C (68-77°F)
do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing

Inactive Ingredents

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, glycerin, hypromellose, mix berry flavor, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments

OTC - QUESTIONS SECTION

Call 1-877-244-9825

*All trademarks are the property of their respective owners.

Manufactured for:

Taro Pharmaceuticals U.S.A., Inc.

Hawthrone, NY 10532

TARO is a registered trademark of

Taro Pharmaceuticals U.S.A., Inc.

Made in India

Revised: 08/2024

IBUPROFEN suspension

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	2
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	2
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	2
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7653-0	ibuprofen	1 in 1 CARTON	SUSPENSION	1		2
50090-7653-0	ibuprofen	120 mL in 1 BOTTLE, PLASTIC	SUSPENSION	120		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7653-0	ML - Milliliter	50090-7653	912a8c74-02b4-479a-9808-7a92d407463d	1	2025-10-14
51672-5321-8	ML - Milliliter	51672-5321	3223b3f8-fa6d-4b6a-bcc8-3189b2679029	1	2025-05-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

ibuprofen
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
GLYCERIN
HYDROXYPROPYL METHYLCELLULOSE
PEG-20 SORBITAN OLEATE
SODIUM BENZOATE
SUCROSE
WATER
XANTHAN GUM
PROPYLENE GLYCOL
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-7653	50090-7653-0
51672-5321

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYDROXYPROPYL METHYLCELLULOSE	3NXW29V3WO	IACT
PEG-20 SORBITAN OLEATE	6OZP39ZG8H	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TRIACETIN	XHX3C3X673	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211666-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2021-02-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211666-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2021-02-22	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	9de61620-6750-4fb6-89a4-fe451ab8d99f	2026-07-15	Warnings	Exact identifier ndc (product): 51672-5321
ibuprofen	IBUPROFEN	A-S Medication Solutions	7d4ba8be-df59-4a21-8850-8a59bf72b604	2025-09-11	Warnings	Exact identifier ndc (package): 50090-7653-0 ndc (product): 50090-7653 ndc11 (package): 50090765300 spl id: 65d7cba1-ee25-42e5-908f-a0e1e3416914 spl set id: 7d4ba8be-df59-4a21-8850-8a59bf72b604

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.