CHILDRENS ADVIL

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-02-08
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:08:26

Label at a glance#

ProductCHILDRENS ADVIL

Active ingredientIBUPROFEN

Label structure10 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 • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspensi...

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Websitewww.advil.com

www.Advil.com

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Fever reducer/Pain reliever

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:

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 the 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 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 the child
child has problems or serious side effects from taking pain relievers or fever reducers
child has a history of stomach problems, such as heartburn
child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
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

take 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

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
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise use age.
repeat dose every 6-8 hours, if needed
do not use more than 4 times a day
measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL)
under 24 lb	under 2 yr	ask a doctor
24-35 lb	2-3 yr	5 mL
36-47 lb	4-5 yr	7.5 mL
48-59 lb	6-8 yr	10 mL
60-71 lb	9-10 yr	12.5 mL
72-95 lb	11 yr	15 mL

Other information

SPL UNCLASSIFIED SECTION

each 5 mL contains: sodium 10 mg
one dose lasts 6-8 hours
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

Additional Information

SPL UNCLASSIFIED SECTION

Long Lasting: Up to 8 hours of fever reduction

Great Convenience: Long duration means fewer doses needed per day.

Alcohol-Free

For most recent production information,

Visit www.Advil.com

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years – 11 years.

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC0573-1174-12

Children's
Advil^®
Suspension

Ibuprofen Oral Suspension
100 mg per 5 mL
Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains
Lasts Up To
8
Hours

Same Great Flavor!
Now Dye-Free

Dye-Free

BLUE RASPBERRY

Blue Raspberry-Flavored Liquid
for ages 2-11 years

4 FL OZ (120 mL)
Alcohol-Free

PAA105480 Front Carton

Children's Advil Suspension BR Dye-Free 4 FL oz (120 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
206878	Advil Children 100 MG in 5 mL Oral Suspension	PSN	5
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	5
206878	ibuprofen 20 MG/ML Oral Suspension [Advil]	SBD	5
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	5
206878	Advil 100 MG per 5 ML Oral Suspension	SY	5
206878	Advil 20 MG/ML Oral Suspension	SY	5
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	5
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	5

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
0573-1174-12	CHILDRENS ADVIL	120 mL in 1 BOTTLE	SUSPENSION	120		5
0573-1174-12	CHILDRENS ADVIL	1 in 1 CARTON	SUSPENSION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-1174	CHILDRENS ADVIL (IBUPROFEN) SUSPENSION [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240209_4eba2795-e826-480d-afdc-d62004e95f36.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-1174-12	ML - Milliliter	0573-1174	8832558f-1e2f-4c5c-85ec-f94661da7f02	1	2025-01-14

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

CHILDRENS ADVIL
ibuprofen
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SORBITOL
SUCROSE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0573-1174	0573-1174-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SORBITOL	506T60A25R	IACT
SUCROSE	C151H8M554	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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020589-001	CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1996-06-27
N020589-002	CHILDREN'S ADVIL-FLAVORED	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1997-11-07

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 3 · 86 observed 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	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`74a2ff9319b5…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`cb3db0bc1861…`

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
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	4eba2795-e826-480d-afdc-d62004e95f36	2024-02-08	Warnings	Exact identifier ndc (package): 0573-1174-12 ndc (product): 0573-1174 ndc11 (package): 00573117412 spl id: e78c4482-deac-46a8-8774-856e1fe5054c spl set id: 4eba2795-e826-480d-afdc-d62004e95f36

Reported adverse events (FAERS/openFDA)#

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