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. • 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 mai...
• each 5 mL 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
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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:
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)
Dosing Chart | ||
Weight (lb) | Age (yr) | Dose (mL)** |
under 24 lbs | 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
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
1-800-719-9260
| 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 |
|---|---|---|---|---|---|---|
| 71205-395-72 | ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 1 | |
| 71205-395-72 | ibuprofen | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-395-72 | ML - Milliliter | 71205-395 | e1149996-108f-48c1-b89b-50433cd4db05 | 1 | 2020-04-20 |
| 45802-897-26 | ML - Milliliter | 45802-897 | 786e070a-ced5-429e-8b45-5a0fbbe0609b | 1 | 2012-07-24 |
| 45802-897-34 | ML - Milliliter | 45802-897 | 8afa8c9e-e795-4553-920a-3d81526730ff | 1 | 2014-06-03 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71205-395 | 71205-395-72 |
| 45802-897 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A074937-001 | CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 |
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 | A074937-001 | CHILDREN'S IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1998-12-22 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| ibuprofen | IBUPROFEN | Padagis Israel Pharmaceuticals Ltd | 02889717-204c-463b-8506-4c5cf18c77d3 | 2025-03-03 | Warnings | 45802-897 |
| ibuprofen | IBUPROFEN | Proficient Rx LP | 6d84ed87-b643-46e2-96d4-2052f41bd936 | 2020-02-01 | Warnings | 71205-395-72 71205-395 71205039572 6d84ed87-b643-46e2-96d4-2052f41bd936 6d84ed87-b643-46e2-96d4-2052f41bd936 |
Adverse event summaries are temporarily unavailable. Other product information remains available.