Ibuprofen Oral Suspension USP 50 mg per 1.25 mL

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-04-10
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:09

Label at a glance#

ProductInfants Ibuprofen
Active ingredientIBUPROFEN
Label structure15 sections

Indications and uses

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

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 below. If possible, use weight to dose; otherwise use age. mL = milliliter measure with the dosing device provided. Do not use with any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6 to 8 hours...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 1.25 mL)

Ibuprofen USP 50 mg (NSAID)*


*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

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 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 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 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
    • 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

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 below. If possible, use weight to dose; otherwise use age.
  • mL = milliliter
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child's mouth, toward the inner cheek
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lb)
Age (mos)
Dose (mL)
under 6 mos
ask a doctor
12 to 17 lbs
6 to 11 mos
1.25 mL
18 to 23 lbs
12 to 23 mos
1.875 mL

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-227-07
For Ages 6 Mos. to 23 Mos.
Concentrated Infants' Drops
Ibuprofen Oral Suspension,
USP (NSAID)
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only with enclosed syringe.
Berry Flavor
1 fl oz (30 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-227-07
#Compare to the active ingredient
in Motrin® Infants' Drops
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen Oral
Suspension, USP
(NSAID)
50 mg per 1.25 mL

Pain Reliever/
Fever Reducer
(NSAID)
Concentrated Drops
Lasts up to 8 hours

Use only
with
enclosed
syringe.

Berry Flavor
1 fl oz (30 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Carton Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Carton Label



DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSN1
204442ibuprofen 40 MG/ML Oral SuspensionSCD1
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSY1
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSY1

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-227-04Infants Ibuprofen1 in 1 CARTONSUSPENSION11
58602-227-04Infants Ibuprofen15 mL in 1 BOTTLESUSPENSION151
58602-227-07Infants Ibuprofen30 mL in 1 BOTTLESUSPENSION301
58602-227-07Infants Ibuprofen1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-227INFANTS IBUPROFEN (IBUPROFEN) SUSPENSION [AUROHEALTH LLC]1Current NDC, 4 package rows20240418_2a48af51-23e2-4fec-a76b-eef1611750f5.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-22758602-227-04, 58602-227-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
A213506-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-0884e616aacf4f…
2026-08-18 06:07:402026-07A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-088072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213506-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2024-04-08a50c72e98297…

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
Infants IbuprofenIBUPROFENAurohealth LLC2a48af51-23e2-4fec-a76b-eef1611750f52024-04-10WarningsExact identifier
ndc (package): 58602-227-04
ndc (package): 58602-227-07
ndc (product): 58602-227
ndc11 (package): 58602022707
ndc11 (package): 58602022704
spl id: 2a48af51-23e2-4fec-a76b-eef1611750f5
spl set id: 2a48af51-23e2-4fec-a76b-eef1611750f5

Reported adverse events (FAERS/openFDA)#

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