Indications and uses
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
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...
Read all product information before using. Keep this insert for important information. This product is intended for use in children.
Pain reliever/fever reducer
temporarily:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
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)
| 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 | ||
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.
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum
Call 1-800-845-8210.
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
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

| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-1022-00 | Dye Free Childrens Ibuprofen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 11 | |
| 0121-1022-00 | Dye Free Childrens Ibuprofen | 10 in 1 CASE | SUSPENSION | 10 | 11 | |
| 0121-1022-05 | Dye Free Childrens Ibuprofen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 11 | |
| 0121-1022-05 | Dye Free Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | 11 | |
| 0121-2044-00 | Dye Free Childrens Ibuprofen | 10 in 1 CASE | SUSPENSION | 10 | 11 | |
| 0121-2044-00 | Dye Free Childrens Ibuprofen | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | 11 | |
| 0121-2044-10 | Dye Free Childrens Ibuprofen | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | 11 | |
| 0121-2044-10 | Dye Free Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | 11 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0121-1022 | DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 11 | 4 package rows | 20250205_a616a7cd-4814-478e-8c58-7fbc2454d992.zip |
| 0121-2044 | DYE FREE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 11 | 4 package rows | 20250205_a616a7cd-4814-478e-8c58-7fbc2454d992.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1022-00 | ML - Milliliter | 0121-1022 | 617a8c34-bf42-43c5-8ece-3babf1df40ad | 1 | 2024-05-16 |
| 0121-1022-05 | ML - Milliliter | 0121-1022 | c1a7b17a-8fc5-4d8a-b685-09b35eb6499f | 1 | 2023-12-05 |
| 0121-2044-00 | ML - Milliliter | 0121-2044 | 34c30b06-c905-48c8-a983-4eab2b7e1ebb | 1 | 2024-05-16 |
| 0121-2044-10 | ML - Milliliter | 0121-2044 | 12112020-3de3-4cef-8efa-0c4038716916 | 1 | 2024-05-16 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0121-1022 | 0121-1022-05, 0121-1022-00 |
| 76281-128 | |
| 0121-2044 | 0121-2044-10, 0121-2044-00 |
| 76281-119 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210602-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3a93d1ddd44b… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspension Dye free | IBUPROFEN | AptaPharma Inc. | bb995c57-a2cc-4bc7-9c7d-f885c425be64 | 2026-05-10 | Warnings | 76281-128 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | AptaPharma Inc. | 40936019-74ab-4b25-a502-7bbc6e12034a | 2025-12-26 | Warnings | 76281-119 |
| d1635350-9966-4795-9bc2-6cf2b690eaec | a616a7cd-4814-478e-8c58-7fbc2454d992 | 2025-01-31 | Warnings | d1635350-9966-4795-9bc2-6cf2b690eaec a616a7cd-4814-478e-8c58-7fbc2454d992 |
Adverse event summaries are temporarily unavailable. Other product information remains available.