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...
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).
Dosing Chart | ||
Weight (lb) | Age (mos) | Dose (mL) |
under 6 mos | ask a doctor | |
12 to 17 lbs | 6 to 11 mos | 1.25 mL |
18 to 23 lbs | 12 to 23 mos | 1.875 mL |
carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Actavis
Compare to the active ingredient in Concentrated Motrin® Infants’ Drops†
NDC 71205-110-30
See New Warnings
For Ages 6 Mos. to 23 Mos.
Infants’ Ibuprofen
Concentrated Ibuprofen Oral Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Non-Staining
Use only with enclosed syringe
Dye-Free Berry Flavor
Alcohol Free
½ FL OZ (15 mL)
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320

| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-110-30 | ML - Milliliter | 71205-110 | 4a225811-e248-4f1e-a463-1d5aeba1b82f | 1 | 2018-12-13 |
| 45963-125-23 | ML - Milliliter | 45963-125 | de6b7eaa-971a-4783-882d-c51fe1aa59d9 | 1 | 2012-07-24 |
| 45963-125-24 | ML - Milliliter | 45963-125 | 9a99be24-ed02-4b6b-9378-5fbb14ac8374 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71205-110 | 71205-110-15, 71205-110-30 |
| 45963-125 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ALCOHOL | 3K9958V90M | CNTM |
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 |
|---|---|---|---|---|---|---|---|
| A079058-001 | IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 |
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 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079058-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2009-08-31 | 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 |
|---|---|---|---|---|---|---|
| 33d5fc76-e9d2-4c1d-a9ac-8441baa25259 | d1fbc5ce-bd0e-4ac4-a77c-b159acfe7f4e | 2025-05-01 | Warnings | d1fbc5ce-bd0e-4ac4-a77c-b159acfe7f4e |
Adverse event summaries are temporarily unavailable. Other product information remains available.