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) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-...
Important: 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.
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 (1 unit dose cup) |
36-47 lbs | 4-5 years | 7.5 mL (1.5 unit dose cups) |
48-59 lbs | 6-8 years | 10 mL (2 unit dose cups) |
60-71 lbs | 9-10 years | 12.5 mL (2.5 unit dose cups) |
72-95 lbs | 11 years | 15 mL (3 unit dose cups) |
* or as directed by a doctor
Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:
5 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐743‐17
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.
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin ® Dye-Free Berry Flavor.
DO NOT USE IF SEAL IS BROKEN.
Distributed by:
American Health Packaging
Columbus, OH 43217
R07/23
Case NDC 60687-743-17/Cup NDC 60687-743-40
Children’s Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol Free
SHAKE WELL
USUAL DOSAGE: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
For Institutional Use Only.
T1022C050723 R07/23
NDC 60687- 743-40
Children's Ibuprofen
Oral Suspension, USP
(NSAID)
Pain Reliever/Fever Reducer
100 mg per 5 ml
Berry Flavored/Dye Free/ Alcohol Free
Delivers 5 mL
SHAKE WELL
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
A1022C05/1023
| 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 |
|---|---|---|---|---|---|---|
| 60687-743-17 | Childrens Ibuprofen | 10 in 1 CASE | SUSPENSION | 10 | 1 | |
| 60687-743-40 | Childrens Ibuprofen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 1 | |
| 60687-743-46 | Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60687-743-17 | ML - Milliliter | 60687-743 | fdb3fb50-c6ac-4bad-a003-2394ef415e6c | 1 | 2024-01-04 |
| 60687-743-40 | ML - Milliliter | 60687-743 | 3fdce689-2035-4cdb-8c6b-e7abf6f1ec40 | 1 | 2024-01-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 60687-743 | 60687-743-40, 60687-743-46, 60687-743-17 |
| 76281-128 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | f41ea6bd6efb… |
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 | IBUPROFEN | American Health Packaging | bc69d88b-d9af-4010-8e8f-e761a9e295a9 | 2023-12-05 | Warnings | 60687-743-40 60687-743-46 60687-743-17 60687-743 60687074346 60687074340 60687074317 0bcab4c1-507c-4dfe-e063-6294a90af06d bc69d88b-d9af-4010-8e8f-e761a9e295a9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.