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 every 6 to 8 hours...
store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing see bottom panel of carton for lot number and expiration date
Drug Facts
Pain reliever/fever reducer
temporarily:
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:
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.
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 (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 |
berry flavor natural & artificial, caramel, citric acid (anhydrous), glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Call 1-866-923-4914
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
*Compare to the active
ingredient in
Motrin
®Infants' Drops
NDC 51672-2146-3
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen
Oral Suspension (NSAID)
50 mg per 1.25 mL
Pain reliever / Fever reducer
Dye-Free
Alcohol Free
Use only with
enclosed
syringe.
Lasts
up to
8 hours
Berry Flavor
1 FL OZ (30 mL)

| 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 |
|---|---|---|---|---|---|---|
| 51672-2146-3 | IBUPROFENInfants | 30 mL in 1 BOTTLE | SUSPENSION/ DROPS | 30 | 6 | |
| 51672-2146-3 | IBUPROFENInfants | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 6 | |
| 51672-2146-5 | IBUPROFENInfants | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | 6 | |
| 51672-2146-5 | IBUPROFENInfants | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51672-2146 | 51672-2146-3, 51672-2146-5 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARAMEL | T9D99G2B1R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|---|
| A217261-001 | IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 |
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 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217261-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2023-08-08 | a50c72e98297… |
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 Infants | IBUPROFEN | Sun Pharmaceutical Industries, Inc. | bc816597-a85a-4143-9f99-bb0699ca57c5 | 2026-03-23 | Warnings | 51672-2146-3 51672-2146-5 51672-2146 51672214603 51672214605 4db5c2e1-85e1-4689-e063-6294a90aaf91 bc816597-a85a-4143-9f99-bb0699ca57c5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.