Indications and uses
temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, headache and toothaches
Ibuprofen
- Manufacturer
- Strides Pharma Inc | Strides Pharma Global Pte. Ltd.
- Effective date
- 2022-06-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:55:45
Label at a glance#
ProductIbuprofen
Active ingredientIBUPROFEN
Label structure10 sections
Dosage and administration
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. If possible, use weight to dose; otherwise use age. repeat dose every 6-8 hours, if needed do not use more than 4 times a day measure with the dosing device provided. Do not use with any other device. Dosing Chart Weight (lb) Age (mos) Dose (mL) under 6 mos...
Storage and handling
one dose lasts 6-8 hours store at 20-25°C (68-77°F) see bottom of box for lot number and expiration date
Contacts and useful links#
Websitewww.strides.com
www.strides.com
www.strides.comLabel contents#
Full prescribing information#
Active ingredient (in each 1.25 mL)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Fever reducer/Pain reliever
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, headache and toothaches
Warnings
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
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:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- takes more or for a longer time than directed
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.
Do not use
- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to your child
- child has problems or serious side effects from taking pain relievers or fever reducers
- child has a history of stomach problems, such as heartburn
- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
- child has not been drinking fluids
- child has lost a lot of fluid due to vomiting or diarrhea
- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- child experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- child does not get any relief within first day (24 hours) of treatment
- fever or pain gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
OTC - KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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. If possible, use weight to dose; otherwise use age.
- repeat dose every 6-8 hours, if needed
- do not use more than 4 times a day
- measure with the dosing device provided. Do not use with any other device.
| Weight (lb) | Age (mos) | Dose (mL) |
| under 6 mos | ask a doctor | |
| 12-17 lb | 6-11 mos | 1.25 mL |
| 18-23 lb | 12-23 mos | 1.875 mL |
Other Information
- one dose lasts 6-8 hours
- store at 20-25°C (68-77°F)
- see bottom of box for lot number and expiration date
Inactive ingredients
citric acid monohydrate, edetate disodium dihydrate, glycerin, microcrystalline cellulose, natural and artificial flavors, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose and xanthan gum
Questions or comments?
Call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825 or ask your pharmacist, doctor or health care professional or visit www.strides.com.
Manufactured by:
Strides Pharma Science Limited
Bengaluru - 562106, India.
Distributed by:
Strides Pharma Inc.,
East Brunswick, NJ 08816
Revised: 05/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
See New Warnings
NDC 59556-149-01
For Ages 6-23 Months
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 5 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Mix Berry Flavor
1/2 fl oz (15 mL)
See New Warnings
NDC 59556-149-02
For Ages 6-23 Months
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 5 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Alcohol Free
Mix Berry Flavor
1 fl oz (30 mL)
Products#
Every source-derived product name is available through these pages.
- Ibuprofen
- GLYCERIN
- POLYSORBATE 80
- SODIUM BENZOATE
- SUCROSE
- XANTHAN GUM
- WATER
- NONCRYSTALLIZING SORBITOL SOLUTION
- CITRIC ACID MONOHYDRATE
- CELLULOSE, MICROCRYSTALLINE
- CARBOXYMETHYLCELLULOSE SODIUM
- EDETATE DISODIUM
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59556-149 | 59556-149-02, 59556-149-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| WATER | 059QF0KO0R | IACT |
| NONCRYSTALLIZING SORBITOL SOLUTION | 9E0S3UM200 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214071-001 | IBUPROFEN | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 |
Observed Orange Book product history#
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 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214071-001 | IBUPROFEN | 50MG/1.25ML | SUSPENSION/DROPS / ORAL | 2022-06-09 | a50c72e98297… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| a06d7f3c-9797-4279-a0ef-f1d15edf25bb | 35e9c1c0-a864-41a9-b3bb-4ddecc343dde | 2022-11-11 | Warnings | 35e9c1c0-a864-41a9-b3bb-4ddecc343dde |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.