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...
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 (1-800-222-1222) right away.
Dosing Chart
| 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, artificial bubble gum flavor, citric acid anhydrous, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredient in Children's Motrin®†
FOR AGES 2-11 YEARS
CHILDREN'S
IBUPROFEN
FEVER REDUCER & PAIN RELIEVER
(NSAID) oral suspension
IBUPROFEN
100 mg/5 mL
lasts up to 8 hours
shake well before using
alcohol
BUBBLE GUM FLAVOR
dosage cup included
FL OZ (mL)
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®.
TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING.
DISTRIBUTED BY:
RITE AID,
30 HUNTER LANE,
CAMP HILL, PA 17011
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-3061-6 | 2023-10-31 | C162847 | 48780-1 | f386c64a-05b2-0266-e053-dadaa90a7c1a | Ibuprofen Oral Suspension, USP |
| 11822-3061-6 | 2023-01-30 | C162847 | 48780-1 | f386c64a-05b2-0266-e053-dadaa90a7c1a | Ibuprofen Oral Suspension, USP |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-3061-6 | IbuprofenChildrens | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 5 | |
| 11822-3061-6 | IbuprofenChildrens | 1 in 1 BOX | SUSPENSION | 1 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-3061 | IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION] | 5 | Legacy NDC, 2 package rows | 20241109_cff88afe-45f1-44ed-ab92-89c0086aacd0.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-3061 | 11822-3061-6 |
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 |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|---|
| A074916-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 |
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 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074916-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 1999-04-30 | 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 |
|---|---|---|---|---|---|---|
| 23163529-4bf4-464b-818b-db9b21a4eb13 | cff88afe-45f1-44ed-ab92-89c0086aacd0 | 2024-11-08 | Warnings | 23163529-4bf4-464b-818b-db9b21a4eb13 cff88afe-45f1-44ed-ab92-89c0086aacd0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.