Ibuprofen Oral Suspension, USP

Manufacturer
Rite Aid Corporation
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:36:16

Label at a glance#

ProductIbuprofen Childrens
Active ingredientIBUPROFEN
Label structure10 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 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 others drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a 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 a 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 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

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 wit 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 stool
    • 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

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 years 10 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 5 mL contains: 2 mg
  • store between 20º to 25ºC (68º to 77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

www.riteaid.com

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Ibuprofen 100 mg/5 mL Bubble Gum Flavor
Children's Ibuprofen 100 mg/5 mL Bubble Gum Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN5
197803ibuprofen 20 MG/ML Oral SuspensionSCD5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3061-62023-10-31C16284748780-1f386c64a-05b2-0266-e053-dadaa90a7c1aIbuprofen Oral Suspension, USP
11822-3061-62023-01-30C16284748780-1f386c64a-05b2-0266-e053-dadaa90a7c1aIbuprofen Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3061-6IbuprofenChildrens118 mL in 1 BOTTLESUSPENSION1185
11822-3061-6IbuprofenChildrens1 in 1 BOXSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3061IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]5Legacy NDC, 2 package rows20241109_cff88afe-45f1-44ed-ab92-89c0086aacd0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-306111822-3061-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
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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2026-08-18 06:07:402026-07A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30a72a2bbeb626…
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…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30f41ea6bd6efb…

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
23163529-4bf4-464b-818b-db9b21a4eb13cff88afe-45f1-44ed-ab92-89c0086aacd02024-11-08WarningsExact identifier
spl id: 23163529-4bf4-464b-818b-db9b21a4eb13
spl set id: cff88afe-45f1-44ed-ab92-89c0086aacd0

Reported adverse events (FAERS/openFDA)#

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