Children's Ibuprofen Oral Suspension (NSAID)
- Manufacturer
- WinCo Foods, LLC | Aptapharma Inc.
- Effective date
- 2020-09-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:13:46
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Ibuprofen 100 mg (NSAlD)*
*nonsteroidal anti-infammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses temporarily:
■ relieves minor aches and pains due to the common cold,
flu, sore throat, headache and toothache
■ reduces fever
WARNINGS SECTION
Warnings
SPL UNCLASSIFIED SECTION
Allergy alert: Ibuprofen may cause asevere 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.
SPL UNCLASSIFIED SECTION
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 ablood 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
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Do not use
■ if the child has ever had an allergic reaction to Ibuprofen
or any other pain reliever/fever reducer
■ right before or after heart surgery
SPL UNCLASSIFIED SECTION
Ask a doctor before use if
■ stomach bleeding warning applies to your child
■ child has a history of stomach problems, such as
heartburn
■ child has problems or serious side effects from taking
pain relievers or fever reducers
■ child has not been drinking fluids
■ child has lost a lot of fluid due to vomiting or diarrhea
■ child has high blood pressure, heart disease, liver
cirrhosis, kidney disease, or had a stroke
■ child has asthma
■ child is taking a diuretic
SPL UNCLASSIFIED SECTION
Ask a doctor or pharmacist before use if the child is
■ under a doctor's care for any serious condition
■ taking any other drug
SPL UNCLASSIFIED SECTION
When using this product
■ take with food or milk if stomach upset occurs
SPL UNCLASSIFIED SECTION
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
■ the 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 SECTION
Keep out of reach of children. In case of overdose, get
medical help or contact aPoison Control Center right
away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions
■ 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 resistance
| 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
OTHER SAFETY INFORMATION
Other information
■ each 5 mL contains: sodium 2 mg
■ store between 20-25ºC (68-77ºF)
■ do not use if carton is opened or printed bottle
neckband is broken or missing
■ see bottom panel for lot number and expiration date
INACTIVE INGREDIENT SECTION
Inactive ingredients
Acesulfame potassium, anhydrous citric. acid,
carboxymethylcellulose sodium, flavors, glycerin,
microcrystalline cellulose, polysorbate 80, propylene
glycol, purified water, sodium benzoate, sucrose,
and xanthan gum
OTC - QUESTIONS SECTION
Questions?
Call 800·824·1706 Monday - Friday gam - 4pm MST
Package Labeling
WinCo®
FOODS
Children's
Ibuprofen
Oral Suspension
(NSAID)
**Compare to the active ingredient
in Children's MOTRIN®
IBUPROFEN
100 mg per 5 mL
PAIN RELIEVER/FEVER REDUCER
Alcohol Free
Lasts Up To 8 Hours
For Ages 2 to 11 Years
Dye
Free
Original
Berry Flavor
4 FL OZ (118 mL)
Important: Read all product informatlon before using.
Keep this box tor important informatlon,
This product is intended lor use in children.
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
** This product is not manufactured or distributed by
MCNEIL CONSUMER HEALTHCARE, distributor of
Children's MOTRIN®.
KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION.
BX-l09 WF2004
0 70552 25076 5
Carton Label
Bottle Label
res
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67091-367-04 | 2022-12-16 | C162847 | 48780-1 | d6a99b39-47dc-a426-e053-dadaa90af4c2 | Children's Ibuprofen Oral Suspension (NSAID) |
| 67091-367-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-47dc-a426-e053-dadaa90af4c2 | Children's Ibuprofen Oral Suspension (NSAID) |
Products#
Every source-derived product name is available through these pages.
- WinCo Foods Childrens Ibuprofen
- Childrens Ibuprofen Oral Suspension
- IBUPROFEN
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM
- GLYCERIN
- MICROCRYSTALLINE CELLULOSE
- POLYSORBATE 80
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SUCROSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67091-367 | 67091-367-04 |
Ingredients#
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 |
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 |
|---|---|---|---|---|---|---|---|
| A210602-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 |
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 | 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210602-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2018-11-23 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| a4385c0f-c47d-4b28-a683-89a12c264a28 | e66d8508-845b-4417-8337-ed9de794510b | 2022-12-16 | Warnings | e66d8508-845b-4417-8337-ed9de794510b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

