Childrens Ibuprofen

Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:54:19

Label at a glance#

ProductDye Free Childrens Ibuprofen
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. 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  under 2 years  ask a doctor  24-35 lbs  2-3 years  5 mL  36-4...

Label contents#

Full prescribing information#

Important:

SPL UNCLASSIFIED SECTION

Read all product information before using. Keep this insert for important information. This product is intended for use in children.

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 100 mg (NSAID)1 

1 nonsteroidal 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

SPL UNCLASSIFIED 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

Heart attack and stroke warning: 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: 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. 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 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

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 2 mg
  • store between 20° to 25°C (68° to 77°F)

Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:

NDC 0121-1022-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1022-00;  Case contains 100 unit dose cups of 5 mL (0121-1022-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2044-10:  10 mL Unit dose cup
NDC 0121-2044-00:  Case contains 100 unit dose cups of 10 mL (0121-2044-10) packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

*All trademarks are property of their respective owners.

SPL UNCLASSIFIED SECTION

This product is not affiliated with the makers/owners of Children's Motrin® Dye-Free Berry Flavor.

PACKAGED BY
PAI Pharma
Greenville, SC 29605

R07/23

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0121-1022-05

Dye Free Children's Ibuprofen
Oral Suspension, USP
(NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

PAI Pharma
Greenville, SC 29605

SEE DRUG FACTS

Children's Ibuprofen Oral Suspension USP - 5mL lidding label
Children's Ibuprofen Oral Suspension USP - 5mL lidding label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  0121-2044-10

Dye Free Children's Ibuprofen
200 mg per 10 mL

Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

PAI Pharma
Greenville, SC 29605

SEE DRUG FACTS

Lidding
Lidding

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN11
197803ibuprofen 20 MG/ML Oral SuspensionSCD11
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY11
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY11

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
0121-1022-00Dye Free Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION511
0121-1022-00Dye Free Childrens Ibuprofen10 in 1 CASESUSPENSION1011
0121-1022-05Dye Free Childrens Ibuprofen5 mL in 1 CUP, UNIT-DOSESUSPENSION511
0121-1022-05Dye Free Childrens Ibuprofen10 in 1 TRAYSUSPENSION1011
0121-2044-00Dye Free Childrens Ibuprofen10 in 1 CASESUSPENSION1011
0121-2044-00Dye Free Childrens Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION1011
0121-2044-10Dye Free Childrens Ibuprofen10 mL in 1 CUP, UNIT-DOSESUSPENSION1011
0121-2044-10Dye Free Childrens Ibuprofen10 in 1 TRAYSUSPENSION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1022DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]114 package rows20250205_a616a7cd-4814-478e-8c58-7fbc2454d992.zip
0121-2044DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]114 package rows20250205_a616a7cd-4814-478e-8c58-7fbc2454d992.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1022-00ML - Milliliter0121-1022617a8c34-bf42-43c5-8ece-3babf1df40ad12024-05-16
0121-1022-05ML - Milliliter0121-1022c1a7b17a-8fc5-4d8a-b685-09b35eb6499f12023-12-05
0121-2044-00ML - Milliliter0121-204434c30b06-c905-48c8-a983-4eab2b7e1ebb12024-05-16
0121-2044-10ML - Milliliter0121-204412112020-3de3-4cef-8efa-0c403871691612024-05-16

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
0121-10220121-1022-05, 0121-1022-00
76281-128
0121-20440121-2044-10, 0121-2044-00
76281-119

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210602-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23

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
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2026-09-14 22:38:342026-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23c0c555d07b60…
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2019-09-15 20:21 UTC2019-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233a93d1ddd44b…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Oral Suspension Dye freeIBUPROFENAptaPharma Inc.bb995c57-a2cc-4bc7-9c7d-f885c425be642026-05-10WarningsExact identifier
ndc (product): 76281-128
Childrens Ibuprofen Oral SuspensionIBUPROFENAptaPharma Inc.40936019-74ab-4b25-a502-7bbc6e12034a2025-12-26WarningsExact identifier
ndc (product): 76281-119
d1635350-9966-4795-9bc2-6cf2b690eaeca616a7cd-4814-478e-8c58-7fbc2454d9922025-01-31WarningsExact identifier
spl id: d1635350-9966-4795-9bc2-6cf2b690eaec
spl set id: a616a7cd-4814-478e-8c58-7fbc2454d992

Reported adverse events (FAERS/openFDA)#

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