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#

ProductWinCo Foods Childrens Ibuprofen
Active ingredientIBUPROFEN
Label structure11 sections

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

Dosing Chart 
 Weight (lb) Age (yr)​Dose (mL)*
 under 24 under 2 yearsask a doctor
 24-35 lbs2-3 years5 mL
 36-47 lbs4-5 years7.5 mL
 48-59 lbs6-8 years10 mL
 60-71 lbs9-10 years12.5 mL
 72-95 lbs11 years15 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Winco 367Winco 367

Bottle Label

Winco 367 BtlWinco 367 Btl

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-367-042022-12-16C16284748780-1d6a99b39-47dc-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension (NSAID)
67091-367-042022-01-28C16284748780-1d6a99b39-47dc-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension (NSAID)

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-36767091-367-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210602-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
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2026-08-18 06:07:402026-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23782e0a99824c…
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2021-03-12 10:30 UTC2021-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235aa47cf7b7d7…
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2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233bdfa0b2c4d7…
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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a4385c0f-c47d-4b28-a683-89a12c264a28e66d8508-845b-4417-8337-ed9de794510b2022-12-16WarningsExact identifier
spl set id: e66d8508-845b-4417-8337-ed9de794510b

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