Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • mL = milliliter • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose ev...
• store at 20-25°C (68-77°F) • do not freeze • do not use if printed neckband is broken or missing
Ibuprofen 50 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:
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 (lbs) | Age (mos) | Dose (mL) |
under 6 mos | ask a doctor | |
12-17 lbs | 6-11 mos | 1.25 mL |
18-23 lbs | 12-23 mos | 1.875 mL |
anhydrous citric acid, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
1-800-719-9260
Compare to Motrin® Infants’ Drops active ingredient
See New Warnings
H-E-B®
For Ages 6 Mos. to 23 Mos.
Infants’
Ibuprofen
Oral Suspension 50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 Hours
Non-Staining
DYE FREE
No High Fructose Corn Syrup
Use only with enclosed syringe
Berry Flavor
1 FL OZ (30 mL)

| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-255-10 | infants ibuprofen | 30 mL in 1 BOTTLE | SUSPENSION/ DROPS | 30 | 4 | |
| 37808-255-10 | infants ibuprofen | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37808-255 | 37808-255-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml |
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 |
|---|---|---|---|---|---|---|---|
| A075217-001 | IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 |
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 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075217-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 1998-12-16 | 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 |
|---|---|---|---|---|---|---|
| infants ibuprofen | IBUPROFEN | H E B | 2c67fecb-2e69-44d6-8ab8-3251abae72a6 | 2021-11-16 | Warnings | 37808-255-10 37808-255 37808025510 edea0019-eee0-4c6e-aafb-f8854d012b74 2c67fecb-2e69-44d6-8ab8-3251abae72a6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.