Health Sense Infants Ibuprofen

Manufacturer: Dolgencorp Inc
Effective date: 2009-05-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:22:33

Label at a glance#

ProductHealth Sense Infants Ibuprofen Oral Suspension

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed do not give longer than 10 days, unless directed by a doctor (see Warnings) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise use age. measure with dosing device provided. Do not use with any other device. dispense liquid slowly into the child’s mouth, towa...

Storage and handling

do not use if printed neckband is broken or missing store at 20-25°C (68-77°F) see bottom of box for lot number and expiration date

Contacts and useful links#

PhoneLabel contact1-888-309-9030

Label contents#

Full prescribing information#

Active ingredient (in each 1.25 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if the child:

has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
takes more or for a longer time 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

OTC - DO NOT USE SECTION

if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

problems or serious side effects from taking pain relievers or fever reducers
stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
not been drinking fluids
lost a lot of fluid due to vomiting or diarrhea
high blood pressure
heart or kidney disease
taken a diuretic

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
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
long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

OTC - STOP USE SECTION

the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
stomach pain or upset gets worse or lasts
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.

Directions

DOSAGE & ADMINISTRATION SECTION

this product does not contain directions or complete warnings for adult use
do not give more than directed
do not give longer than 10 days, unless directed by a doctor (see Warnings)
shake well before using
find the right dose on chart below. If possible, use weight to dose; otherwise use age.
measure with dosing device provided. Do not use with any other device.
dispense liquid slowly into the child’s mouth, toward the inner cheek
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

Dosing Chart

Weight (lb)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lbs	6-11 mos	1.25 mL
18-23 lbs	12-23 mos	1.875 mL

Other information

STORAGE AND HANDLING SECTION

do not use if printed neckband is broken or missing
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavor, butylparaben, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient of Motrin® Infants' Drops

Concentrated

For Ages 6 mos.-23 mos.

Infants' Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Alcohol Free

Use Only With Enclosed Syringe

Berry Flavor

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55910-057-05	2025-10-28	C162847	48780-1	9d75b9d0-af69-f424-e053-dadaa90a57ce	Dollar General Health Sense Infants' Ibuprofen Oral Suspension, Berry Flavor Drug Facts
55910-057-05	2020-01-31	C162847	48780-1	9d75b9d0-af69-f424-e053-dadaa90a57ce	Dollar General Health Sense Infants' Ibuprofen Oral Suspension, Berry Flavor Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-057	HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [DOLGENCORP INC]	1	Legacy NDC	20090825_73e309a5-a8c2-4496-aeff-7251b640a45d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

Health Sense Infants Ibuprofen Oral Suspension
ibuprofen

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55910-057	55910-057-05

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB

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
A075217-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			1998-12-16

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	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075217-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	1998-12-16	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
05919450-f20f-42e0-9fad-979150f8373c			73e309a5-a8c2-4496-aeff-7251b640a45d	2025-10-28	Warnings	Exact identifier spl set id: 73e309a5-a8c2-4496-aeff-7251b640a45d

Reported adverse events (FAERS/openFDA)#

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