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 maintain child resist...
each 5 mL contains: sodium 2 mg store between 20-25°C (68-77°F) do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| ||
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | 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 |
Acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, glycerin, hypromellose, mix berry flavor, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
Call 1-877-244-9825
Manufactured by:
Strides Pharma Science Ltd.
Bengaluru - 562106, India.
Distributed by:
Strides Pharma Inc.,
East Brunswick, NJ 08816
Revised: 04/2022
| 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 |
|---|---|---|---|---|---|---|
| 59556-234-01 | Ibuprofen | 240 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 240 | 4 | |
| 59556-234-01 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-234-72 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-234-72 | Ibuprofen | 120 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 120 | 4 | |
| 59556-235-01 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-235-01 | Ibuprofen | 240 mL in 1 CARTON | SUSPENSION | 240 | 4 | |
| 59556-235-72 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-235-72 | Ibuprofen | 120 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 120 | 4 | |
| 59556-876-01 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-876-01 | Ibuprofen | 240 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 240 | 4 | |
| 59556-876-72 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-876-72 | Ibuprofen | 120 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 120 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59556-234 | IBUPROFEN SUSPENSION [STRIDES PHARMA INC] | 4 | 4 package rows | 20250325_c3c600dd-6eec-4304-868e-9642de5e1dac.zip |
| 59556-235 | IBUPROFEN SUSPENSION [STRIDES PHARMA INC] | 4 | 4 package rows | 20250325_c3c600dd-6eec-4304-868e-9642de5e1dac.zip |
| 59556-876 | IBUPROFEN SUSPENSION [STRIDES PHARMA INC] | 4 | Legacy NDC, 4 package rows | 20250325_c3c600dd-6eec-4304-868e-9642de5e1dac.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59556-876 | 59556-876-72, 59556-876-01 |
| 59556-234 | 59556-234-72, 59556-234-01 |
| 59556-235 | 59556-235-01, 59556-235-72 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A211666-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 |
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 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 87673890dc5c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 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 |
|---|---|---|---|---|---|---|
| fb16f029-50e5-45a5-8431-31cd865c09f8 | c3c600dd-6eec-4304-868e-9642de5e1dac | 2026-09-09 | Warnings | c3c600dd-6eec-4304-868e-9642de5e1dac |
Adverse event summaries are temporarily unavailable. Other product information remains available.