FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension

Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:09:12

Label at a glance#

ProductChildrens Ibuprofen Oral Suspension
Active ingredientIbuprofen
Label structure12 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. 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 r...

Storage and handling

■ each 5 mL contains : sodium 2 mg ■ store between 20° to 25°C (68° to 77°F) ■  do not use if carton is opened or if safety seal under cap printed with “SEALED FOR  YOUR PROTECTION” is torn or missing  Children’s Ibuprofen Oral Suspension is a white to off-white suspension supplied in the following: NDC 0121-0833-04: 4 fl oz (120 mL) bottle NDC 0121-0833-81: Case contains 12 cartons of NDC 0121-0833-04. NDC 0121-0...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)1

1nonsteroidal anti-inflammatory drug

Purpose

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

  • 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

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

  • 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.
  • 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
Weight (lb) Age (yr) Dose (mL)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

■ each 5 mL contains: sodium 2 mg
■ store between 20° to 25°C (68° to 77°F)
■ do not use if carton is opened or if safety seal under cap printed with “SEALED FOR  YOUR PROTECTION” is torn or missing 

Children’s Ibuprofen Oral Suspension is a white to off-white suspension supplied in the following:

NDC 0121-0833-04: 4 fl oz (120 mL) bottle
NDC 0121-0833-81: Case contains 12 cartons of NDC 0121-0833-04.

NDC 0121-0833-05: 5 mL unit dose cup.
NDC 0121-0833-00: Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
NDC 0121-0833-40: Case contains 40 unit dose cups of 5 mL packaged in 4 trays of 10 unit dose cups each.

NDC 0121-1666-10: 10 mL unit dose cup.
NDC 0121-1666-00: Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1666-40: Case contains 40 unit dose cups of 10 mL packaged in 4 trays of 10 unit dose cups each.

Inactive ingredients

INACTIVE INGREDIENT SECTION

avicel, citric acid, glycerin, polysorbate 80, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose, xanthan gum. May contain citric acid and sodium citrate dihydrate for pH adjustment.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

MANUFACTURED BY

SPL UNCLASSIFIED SECTION

PAI Pharma

Greenville, SC 29605

R04/24

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0833-05

CHILDREN'S IBUPROFEN
ORAL SUSPENSION, USP

(NSAID)

100 mg per 5 mL

SHAKE WELL
Alcohol Free/Dye Free

For Institutional Use Only

Dist. by: PAI Pharma
Greenville, SC 29605

SEE DRUG FACTS

Ibuprofen - 5 mLIbuprofen - 5 mL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1666-10

CHILDREN'S IBUPROFEN
ORAL SUSPENSION, USP

(NSAID)

200 mg per 10 mL

SHAKE WELL
Alcohol Free/Dye Free

For Institutional Use Only

Dist. by: PAI Pharma
Greenville, SC 29605

SEE DRUG FACTS

 

Ibuprofen - 10 mLIbuprofen - 10 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN8
197803ibuprofen 20 MG/ML Oral SuspensionSCD8
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY8
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0833-00Childrens Ibuprofen Oral Suspension10 in 1 CASESUSPENSION108
0121-0833-00Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108
0121-0833-05Childrens Ibuprofen Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION58
0121-0833-40Childrens Ibuprofen Oral Suspension4 in 1 CASESUSPENSION48
0121-0833-40Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108
0121-1666-00Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108
0121-1666-00Childrens Ibuprofen Oral Suspension10 in 1 CASESUSPENSION108
0121-1666-10Childrens Ibuprofen Oral Suspension10 mL in 1 CUP, UNIT-DOSESUSPENSION108
0121-1666-40Childrens Ibuprofen Oral Suspension4 in 1 CASESUSPENSION48
0121-1666-40Childrens Ibuprofen Oral Suspension10 in 1 TRAYSUSPENSION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0833-00ML - Milliliter0121-0833a218cb62-b428-4e73-b9b8-7cd61bef15ab12025-08-11
0121-0833-05ML - Milliliter0121-0833588c5ecb-1f31-40b7-87f7-84cc769cea3412025-08-11
0121-1666-00ML - Milliliter0121-1666ceba2adc-7b18-400d-a0c5-21496c6e859b12025-08-11
0121-1666-10ML - Milliliter0121-1666455fd6c4-8824-4541-a807-2600528ff6ad12025-08-11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-08330121-0833-05, 0121-0833-40, 0121-0833-00
0121-16660121-1666-10, 0121-1666-40, 0121-1666-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
IbuprofenWK2XYI10QMACTIB
cellulose, microcrystallineOP1R32D61UIACT
anhydrous citric acidXF417D3PSLIACT
glycerinPDC6A3C0OXIACT
polysorbate 806OZP39ZG8HIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
carboxymethylcellulose sodium, unspecified formK679OBS311IACT
sorbitol solution8KW3E207O2IACT
sucroseC151H8M554IACT
xanthan gumTTV12P4NEEIACT
trisodium citrate dihydrateB22547B95KIACT
IbuprofenWK2XYI10QMACTIB
cellulose, microcrystallineOP1R32D61UIACT
anhydrous citric acidXF417D3PSLIACT
glycerinPDC6A3C0OXIACT
polysorbate 806OZP39ZG8HIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
carboxymethylcellulose sodium, unspecified formK679OBS311IACT
sorbitol solution8KW3E207O2IACT
sucroseC151H8M554IACT
xanthan gumTTV12P4NEEIACT
trisodium citrate dihydrateB22547B95KIACT

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214789-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-0884e616aacf4f…
2026-08-18 06:07:402026-07A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-082680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214789-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2024-11-08a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Oral SuspensionIBUPROFENPAI Holdings, LLC dba PAI Pharmac26cefe0-182a-4b03-baeb-b3eb2e0e22672025-08-01WarningsExact identifier
ndc (package): 0121-0833-05
ndc (package): 0121-0833-00
ndc (package): 0121-1666-10
ndc (package): 0121-1666-40
ndc (package): 0121-0833-40
ndc (package): 0121-1666-00
ndc (product): 0121-0833
ndc (product): 0121-1666
ndc11 (package): 00121083305
ndc11 (package): 00121166640
ndc11 (package): 00121166600
ndc11 (package): 00121083300
ndc11 (package): 00121083340
ndc11 (package): 00121166610
spl id: 70b3589f-fd88-4a73-b758-0d456422bd27
spl set id: c26cefe0-182a-4b03-baeb-b3eb2e0e2267

Reported adverse events (FAERS/openFDA)#

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