Ibuprofen Oral Suspension, USP

Manufacturer
Chain Drug Consortium, LLC | Teva Pharmaceuticals USA, Inc.
Effective date
2018-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:40:06

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 every 6 to 8 hours...

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 lbs6 to 11 mos 1.25 mL 
 18 to 23 lbs12 to 23 mos1.875 mL

Other information

OTHER SAFETY INFORMATION

  • 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

See New Warnings

Premier Value®

COMPARE TO THE ACTIVE
INGREDIENT IN CONCENTRATED
MOTRIN® INFANTS’ DROPS†

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

Berry Flavor

Non-Staining

Dye-Free

Alcohol Free

Use only with enclosed syringe

1 FL OZ (30 mL)

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

1 oz carton
1 oz carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS3112
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

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
68016-12568016-125-24

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 398 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRASYNOVIAL0.1 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HENEMA / RECTAL0.01 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / ORAL206 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / ORAL907 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates

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
f9d90f3b-fcbd-4a3c-9890-8263218fb876618d5ddc-fff2-4d50-a328-433f0a86971f2018-12-20WarningsExact identifier
spl set id: 618d5ddc-fff2-4d50-a328-433f0a86971f

Reported adverse events (FAERS/openFDA)#

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