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...
Active ingredient (in each 1.25 mL)
Ibuprofen USP 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
|
Other information
acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/19/1993
AUROHEALTH
NDC 58602-227-07
For Ages 6 Mos. to 23 Mos.
Concentrated Infants' Drops
Ibuprofen Oral Suspension,
USP (NSAID)
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only with enclosed syringe.
Berry Flavor
1 fl oz (30 mL)
AUROHEALTH
NDC 58602-227-07
#Compare to the active ingredient
in Motrin® Infants' Drops
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen Oral
Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever/
Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 hours
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 |
|---|---|---|---|---|---|---|
| 58602-227-04 | Infants Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 1 | |
| 58602-227-04 | Infants Ibuprofen | 15 mL in 1 BOTTLE | SUSPENSION | 15 | 1 | |
| 58602-227-07 | Infants Ibuprofen | 30 mL in 1 BOTTLE | SUSPENSION | 30 | 1 | |
| 58602-227-07 | Infants Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-227 | 58602-227-04, 58602-227-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE 2208 (4000 MPA.S) | 39J80LT57T | IACT |
| NONCRYSTALLIZING SORBITOL SOLUTION | 9E0S3UM200 | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| STARCH, POTATO | 8I089SAH3T | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|---|
| A213506-001 | IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213506-001 | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS / ORAL | 2024-04-08 | 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 |
|---|---|---|---|---|---|---|
| Infants Ibuprofen | IBUPROFEN | Aurohealth LLC | 2a48af51-23e2-4fec-a76b-eef1611750f5 | 2024-04-10 | Warnings | 58602-227-04 58602-227-07 58602-227 58602022707 58602022704 2a48af51-23e2-4fec-a76b-eef1611750f5 2a48af51-23e2-4fec-a76b-eef1611750f5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.