Ibuprofen Oral Suspension, USP

Manufacturer
Proficient Rx LP
Effective date
2019-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:58:03

Label at a glance#

ProductInfants Ibuprofen
Active ingredientIBUPROFEN
Label structure9 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 ev...

Label contents#

Full prescribing information#

Active ingredient (in each 1.25 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 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 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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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

SPL UNCLASSIFIED SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Actavis

Compare to the active ingredient in Concentrated Motrin® Infants’ Drops†

NDC 71205-110-30

See New Warnings

For Ages 6 Mos. to 23 Mos.

Infants’ Ibuprofen

Concentrated Ibuprofen Oral Suspension, USP

(NSAID)

50 mg per 1.25 mL

Pain Reliever

Fever Reducer

Lasts up to 8 hours

Non-Staining

Use only with enclosed syringe

Dye-Free Berry Flavor

Alcohol Free

½ FL OZ (15 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

71205-110-30
71205-110-30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-110INFANTS IBUPROFEN (IBUPROFEN) SUSPENSION [PROFICIENT RX LP]2Legacy NDC20191122_d1fbc5ce-bd0e-4ac4-a77c-b159acfe7f4e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-110-30ML - Milliliter71205-1104a225811-e248-4f1e-a463-1d5aeba1b82f12018-12-13
45963-125-23ML - Milliliter45963-125de6b7eaa-971a-4783-882d-c51fe1aa59d912012-07-24
45963-125-24ML - Milliliter45963-1259a99be24-ed02-4b6b-9378-5fbb14ac837412012-07-24

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
71205-11071205-110-15, 71205-110-30
45963-125

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
A079058-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31

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
2026-09-14 22:38:342026-08A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079058-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2009-08-31f41ea6bd6efb…

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
33d5fc76-e9d2-4c1d-a9ac-8441baa25259d1fbc5ce-bd0e-4ac4-a77c-b159acfe7f4e2025-05-01WarningsExact identifier
spl set id: d1fbc5ce-bd0e-4ac4-a77c-b159acfe7f4e

Reported adverse events (FAERS/openFDA)#

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