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 resis...
Drug Facts
Active ingredient (in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert: Ibuprofen may cause 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 a 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 |
*or as directed by a doctor
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum
Call 1-888-588-1418 from 9 AM to 5 PM ET, Monday-Friday.
NDC 81522-311-11
†Compare to the active ingredient in Children's Motrin®
FOR AGES 2-11 YEARS
CHILDREN'S IBUPROFEN
100 mg per 5 mL
Oral Suspension, USP (NSAID)
PAIN RELIEVER/FEVER REDUCER
ORIGINAL Berry Flavor
Lasts up to 8 HOURS
4 FL OZ (118mL)
Important: Read all product information before using. Keep this box for important information.
This product is intended for use in children.
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®.
Manufactured for FSA Store Inc.
5473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231
res
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81522-311-11 | Childrens Ibuprofen Oral Suspension Dye Free | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 1 | |
| 81522-311-11 | Childrens Ibuprofen Oral Suspension Dye Free | 1 in 1 CARTON | SUSPENSION | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 81522-311 | 81522-311-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|---|
| A210602-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 |
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 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspension Dye Free | IBUPROFEN | FSA Store Inc. (Caring Mill) | 099e374b-49c2-4d56-a047-d4f0c4af34ba | 2025-09-18 | Warnings | 81522-311-11 81522-311 81522031111 720d2ca9-e3f4-4d00-8d75-2849b51f3553 099e374b-49c2-4d56-a047-d4f0c4af34ba |
Adverse event summaries are temporarily unavailable. Other product information remains available.