Children's Ibuprofen Oral Suspension, USP

Manufacturer
Central Texas Community Health Centers
Effective date
2017-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:27

Label at a glance#

ProductChildrens Ibuprofen
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 find right dose on chart.  If possible, use weight to dose; otherwise use age. use only enclosed measuring cup 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 (tsp ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL = 1 teaspoon)

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
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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 a longer time 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 any other pain reliever/fever reducer
  • right before or after heart surgery

ASK 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, or kidney disease
  • child has asthma
  • child is taking a diuretic

ASK 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • 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
  • the child does not get any relief within the 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 right away (1-800-222-1222).

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
  • find right dose on chart.  If possible, use weight to dose; otherwise use age.
  • use only enclosed measuring cup
  • 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 (tsp or mL)
under 2 yearsask a doctor
24 – 35 lbs2 – 3 years1 tsp or 5 mL
36 – 47 lbs4 – 5 years1½ tsp or 7.5 mL
48 – 59 lbs6 – 8 years2 tsp or 10 mL
60 – 71 lbs9 – 10 years2½ tsp or 12.5 mL
72 – 95 lbs11 years3 tsp or 15 mL

Other information

  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Austin/Travis Co. Health & Human Services Dept.
1000 Toyath St Austin, TX 78702 512-972-6206

IBUPROFEN
100MG/5ML
SUSP.

Date:

Name:
Dr.

TAKE ___ ML BY MOUTH ___ TIMES A DAY.

05/2018

L606011

IBUPROFEN 100MG/5ML ORAL SUSP. #120 NDC 76413-344-01

Batch: 08301708
Lot: L606011
Exp: 05/2018
ACTAVIS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN1
197803ibuprofen 20 MG/ML Oral SuspensionSCD1
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY1
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY1

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
76413-344-012020-01-31C16284748780-19d75b9d0-e437-f424-e053-dadaa90a57ceChildren's Ibuprofen Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-344-01Childrens Ibuprofen118 mL in 1 BOTTLESUSPENSION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-344CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20170909_3987b4e9-a7ac-420a-b040-91562972c9ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-1255-94ML - Milliliter0472-125531f55df6-c09b-4a0f-98a2-648b397e430712012-07-24

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
76413-34476413-344-01
0472-1255

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 · 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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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
d4a5a980-a780-4bb6-a926-8d6648397db03987b4e9-a7ac-420a-b040-91562972c9ee2017-09-08WarningsExact identifier
spl id: d4a5a980-a780-4bb6-a926-8d6648397db0
spl set id: 3987b4e9-a7ac-420a-b040-91562972c9ee

Reported adverse events (FAERS/openFDA)#

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