Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2025-05-12
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:00:49

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure9 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; tsp = teaspoonful 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 6-8 hours do not use more than 4 times a day replace original bottle cap to ma...

Storage and handling

each 5 mL (1 tsp) contains: sodium 2 mg do not use if printed neckband is broken or missing store at 20-25 C (68-77 F) ° ° do not freeze see bottom panel for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL = 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)*

*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: 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

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

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, or kidney disease
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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
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; tsp = teaspoonful
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 6-8 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
Weight (lb)	Age (yr)	Dose (mL or tsp)**
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL (1 tsp)
36-47 lbs	4-5 years	7.5 mL (1½ tsp)
48-59 lbs	6-8 years	10 mL (2 tsp)
60-71 lbs	9-10 years	12.5 mL (2½ tsp)
72-95 lbs	11 years	15 mL (3 tsp)

**or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

each 5 mL (1 tsp) contains: sodium 2 mg
do not use if printed neckband is broken or missing
store at 20-25 C (68-77 F) ^° ^°
do not freeze
see bottom panel for lot number and expiration date

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

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	12
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	12
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	12
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	12

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
17856-5309-1	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-2	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-3	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-4	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-5	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-6	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-7	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-9	2025-03-28	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-1	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-2	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-3	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-4	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-5	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-6	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-7	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-9	2025-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-1	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-2	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-3	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-4	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-5	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-6	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-7	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-9	2023-12-12	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-1	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-2	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-3	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-4	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-5	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-6	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-7	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
17856-5309-9	2023-01-30	C162847	48780-1	f386c64a-321d-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-5309-1	Ibuprofen	5 mL in 1 SYRINGE	SUSPENSION	5	12
17856-5309-2	Ibuprofen	10 mL in 1 SYRINGE	SUSPENSION	10	12
17856-5309-3	Ibuprofen	1 mL in 1 SYRINGE	SUSPENSION	1	12
17856-5309-4	Ibuprofen	20 mL in 1 CUP	SUSPENSION	20	12
17856-5309-5	Ibuprofen	5 mL in 1 CUP	SUSPENSION	5	12
17856-5309-6	Ibuprofen	15 mL in 1 CUP	SUSPENSION	15	12
17856-5309-7	Ibuprofen	7.5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	7.5	12
17856-5309-8	Ibuprofen	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	12
17856-5309-8	Ibuprofen	72 in 1 CASE	SUSPENSION	72	12
17856-5309-9	Ibuprofen	1 mL in 1 SYRINGE	SUSPENSION	1	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-5309	IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]	12	Current NDC, Legacy NDC, 10 package rows	20250514_230914e6-fe0c-45be-8b2e-e066c71d004c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-5309-5	ML - Milliliter	17856-5309	2367354b-add7-439f-ad0e-568dbf9cef44	1	2013-06-04
17856-5309-8	ML - Milliliter	17856-5309	57fe7af4-f076-4408-a7bf-96e936366e42	1	2026-02-05
0904-5309-09	ML - Milliliter	0904-5309	84c04695-1074-42e6-acd5-1135fa49faa9	1	2012-07-24
0904-5309-20	ML - Milliliter	0904-5309	8ae6ee02-bad4-4150-bfb7-98614da02dd7	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

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

Ibuprofen
GLYCERIN
POLYSORBATE 80
ANHYDROUS CITRIC ACID
WATER
SODIUM BENZOATE
SORBITOL
XANTHAN GUM
HIGH FRUCTOSE CORN SYRUP
HYPROMELLOSES
D&C YELLOW NO. 10
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-5309	17856-5309-1, 17856-5309-2, 17856-5309-3, 17856-5309-4, 17856-5309-5, 17856-5309-6, 17856-5309-7, 17856-5309-9, 17856-5309-8
0904-5309

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
GLYCERIN	PDC6A3C0OX	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 132 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SUSPENSION / ORAL		12 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route+dosage form 11 equally ranked IID candidates

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
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 · 43 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	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…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`f41ea6bd6efb…`

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	Major Pharmaceuticals	847758ed-66fc-4db9-8fdb-78f3c3291a03	2026-01-26	Warnings	Exact identifier ndc (product): 0904-5309
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	230914e6-fe0c-45be-8b2e-e066c71d004c	2025-05-12	Warnings	Exact identifier ndc (package): 17856-5309-9 ndc (package): 17856-5309-3 ndc (package): 17856-5309-7 ndc (package): 17856-5309-4 ndc (package): 17856-5309-8 ndc (package): 17856-5309-5 ndc (package): 17856-5309-1 ndc (package): 17856-5309-6 ndc (package): 17856-5309-2 ndc (product): 17856-5309 ndc11 (package): 17856530905 ndc11 (package): 17856530908 ndc11 (package): 17856530904 ndc11 (package): 17856530909 ndc11 (package): 17856530901 ndc11 (package): 17856530903 ndc11 (package): 17856530906 ndc11 (package): 17856530907 ndc11 (package): 17856530902 spl id: 34f37e2c-ba78-120a-e063-6294a90aa750 spl set id: 230914e6-fe0c-45be-8b2e-e066c71d004c

Reported adverse events (FAERS/openFDA)#

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