Ibuprofen Oral Suspension, USP

Manufacturer
Chain Drug Consortium, LLC | P & L Development, LLC
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
legacy-cache
Hydrated at
2026-08-01 20:41:50

Label at a glance#

ProductIbuprofen Childrens
Active ingredientIBUPROFEN
Label structure14 sections

Indications and uses

temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

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 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...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever

Warnings

WARNINGS SECTION

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 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.

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.

Do not use

OTC - DO NOT USE SECTION

  • if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to your child
  • child has a history or 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

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomit 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 last more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 24under 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 information

OTHER SAFETY INFORMATION

  • each 5mL contains: sodium 2 mg
  • store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate,strawberry flavor, sucrose, xanthan gum

Inactive ingredients

INACTIVE INGREDIENT SECTION

Original Berry: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Bubble Gum: 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

Dye-Free Berry: acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum

Grape: acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® BERRY†

Premier Value®

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

● Pain Reliever
● Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Original Berry Flavor 

Alcohol Free 

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® BUBBLE GUM†

Premier Value®

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

● Pain Reliever
● Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Bubble Gum Flavor 

Alcohol Free 

4 FL OZ (118 mL)
PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® GRAPE†

Premier Value®

For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL 

● Pain Reliever 
● Fever Reducer 

Lasts up to 8 hours  

Shake Well
Before Using 

Grape Flavor

Alcohol Free 

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN®†

For Ages 2 to 11 years

Children's Ibuprofen

Oral Suspension, USP (NSAID) 100 mg per 5 mL

  • Pain Reliever
  • Fever Reducer

Lasts up to 8 hours

Shake Well Before Using

Non-Staining

Dye-Free

Berry Flavor

Alcohol Free

FL OZ (mL)

†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: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue, Wayne, PA 19087

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREMIER VALUE Children's Ibuprofen
PREMIER VALUE Children's Ibuprofen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-940IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]15Legacy NDC20250129_c90ad693-174f-4ef8-af01-0ddaebee8902.zip
68016-942IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]15Legacy NDC20250129_c90ad693-174f-4ef8-af01-0ddaebee8902.zip
68016-943IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]15Legacy NDC20250129_c90ad693-174f-4ef8-af01-0ddaebee8902.zip
68016-944IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]15Legacy NDC20250129_c90ad693-174f-4ef8-af01-0ddaebee8902.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Source Document#

Source XML · Source PDF

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
A074916-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30

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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2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-303bdfa0b2c4d7…
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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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4d1113f1-69be-4264-aac3-7a44218e4cd3c90ad693-174f-4ef8-af01-0ddaebee89022025-01-27WarningsExact identifier
spl id: 4d1113f1-69be-4264-aac3-7a44218e4cd3
spl set id: c90ad693-174f-4ef8-af01-0ddaebee8902

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.