CHILDREN'S IBUPROFEN ORAL SUSPENSION

Manufacturer: Precision Dose Inc.
Effective date: 2025-08-08
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:10:27

Label at a glance#

ProductChildrens Ibuprofen

Active ingredientIbuprofen

Label structure14 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

Use as directed per healthcare professional. 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. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor un...

Storage and handling

each 5 mL contains: sodium 2 mg store at 20-25°C (68-77°F) do not freeze

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-397-9228

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Berry Flavor

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

LI1651 Rev. 02/25

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)¹

1 nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

give with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Use as directed per healthcare professional.
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.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

Dosing Chart
Weight (lb)	Age (yr)	Dose (mL)^*
under 24 lbs	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

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 2 mg
store at 20-25°C (68-77°F)
do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

SPL UNCLASSIFIED SECTION

Alcohol Free, Gluten Free

Questions or comments?

OTC - QUESTIONS SECTION

1-800-397-9228

How Supplied

SPL UNCLASSIFIED SECTION

NDC 68094-037-58
5 mL per unit dose ENFit^® syringe
Fifty (50) syringes per shipper

NDC 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper

SPL UNCLASSIFIED SECTION

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email
druginfo@precisiondose.com

LI1651 Rev. 02/25

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68094-494-59
PrecisionDose™

Children's IBUPROFEN
Oral Suspension 100 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 68094-494-58

Children's IBUPROFEN Oral Suspension, 100 mg/5 mL

Delivers 5 mL (NSAID) For Hospital Use Only
Each 5 mL contains: sodium 2 mg
Alcohol Free
Gluten Free
Store at 20°-25°C (68°-77°F) Protect from freezing
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY495 Rev. 04/11

For Oral Use Only

Principal Display Panel - 5 mL Syringe Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	8
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	8
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	8
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	8

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	SPL version
68094-494-58	Childrens Ibuprofen	10 in 1 BAG	SUSPENSION	10	8
68094-494-58	Childrens Ibuprofen	5 in 1 CASE	SUSPENSION	5	8
68094-494-59	Childrens Ibuprofen	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	8
68094-494-61	Childrens Ibuprofen	10 in 1 CASE	SUSPENSION	10	8
68094-494-61	Childrens Ibuprofen	10 in 1 TRAY	SUSPENSION	10	8
68094-494-62	Childrens Ibuprofen	3 in 1 CASE	SUSPENSION	3	8
68094-494-62	Childrens Ibuprofen	10 in 1 TRAY	SUSPENSION	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-494-58	ML - Milliliter	68094-494	4aba43c3-9f5d-4ff0-94d3-03f8c73142a4	1	2012-07-24
68094-494-59	ML - Milliliter	68094-494	ebbd55aa-94b0-485f-9ad2-f8b71d98cd96	1	2012-07-24
68094-494-61	ML - Milliliter	68094-494	0d5aabe9-f0f1-4bad-b9a4-054ca6ec7dad	1	2012-07-24
68094-494-62	ML - Milliliter	68094-494	b89b32c2-d731-4fea-bf52-26447774c88a	1	2012-07-24
0113-0897-26	ML - Milliliter	0113-0897	51dbf351-388a-4cab-8e16-0960b71ee13a	1	2012-07-24
0113-0897-34	ML - Milliliter	0113-0897	035ebb68-87e2-4a78-b0bd-5f4c83214ffe	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Childrens Ibuprofen
Ibuprofen
anhydrous citric acid
D&C yellow NO. 10
FD&C red NO. 40
glycerin
high fructose corn syrup
HYPROMELLOSE, UNSPECIFIED
polysorbate 80
sodium benzoate
water
sorbitol
xanthan gum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68094-494	68094-494-59, 68094-494-62, 68094-494-61, 68094-494-58
0113-0897

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
anhydrous citric acid	XF417D3PSL	IACT
D&C yellow NO. 10	35SW5USQ3G	IACT
FD&C red NO. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
high fructose corn syrup	XY6UN3QB6S	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
polysorbate 80	6OZP39ZG8H	IACT
sodium benzoate	OJ245FE5EU	IACT
water	059QF0KO0R	IACT
sorbitol	506T60A25R	IACT
xanthan gum	TTV12P4NEE	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 44.

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
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`

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
Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	fbbc67a7-359f-4155-9367-3815c05ccf03	2025-08-08	Warnings	Exact identifier ndc (package): 68094-494-61 ndc (package): 68094-494-59 ndc (package): 68094-494-58 ndc (package): 68094-494-62 ndc (product): 68094-494 ndc11 (package): 68094049462 ndc11 (package): 68094049461 ndc11 (package): 68094049459 ndc11 (package): 68094049458 spl id: 5413fd24-141e-4160-b982-0e87370069a3 spl set id: fbbc67a7-359f-4155-9367-3815c05ccf03
good sense ibuprofen childrens	IBUPROFEN	L. Perrigo Company	6127469c-143f-4dd2-bd37-6630291fcd5a	2025-04-30	Warnings	Exact identifier ndc (product): 0113-0897

Reported adverse events (FAERS/openFDA)#

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