Ibuprofen Oral Suspension, USP

Manufacturer
Rite Aid Corporation
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:50:01

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 resistanc...

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

SPL UNCLASSIFIED 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 reliever 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 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 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 (1800-222-1222) 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 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 9-1012.5 mL 
72-95 lbs 11 years 15 mL 

*or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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®†

FREE   |  PARABEN

FROM  |  FREE

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 free

BERRY FLAVOR

DOSAGE CUP INCLUDED

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®.

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children.

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

RITE AID Children's Ibuprofen Berry Flavor
RITE AID Children's Ibuprofen Berry Flavor

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3310IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION]5Legacy NDC20241109_6e2ea68b-13e7-4015-adfd-b7e5e2a40576.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-331011822-3310-4, 11822-3310-5

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
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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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…
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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…
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2020-12-22 03:56 UTC2020-12A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-308869cabd3fbd…
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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…
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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
f38f287b-f008-4cc4-a016-7a032f31b68b6e2ea68b-13e7-4015-adfd-b7e5e2a405762024-11-08WarningsExact identifier
spl id: f38f287b-f008-4cc4-a016-7a032f31b68b
spl set id: 6e2ea68b-13e7-4015-adfd-b7e5e2a40576

Reported adverse events (FAERS/openFDA)#

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