ibuprofen

Manufacturer
Meijer Distribution Inc
Effective date
2021-09-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:34:58

Label at a glance#

Productibuprofen infants
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...

Storage and handling

• store at 20-25°C (68-77°F) • do not freeze • do not use if printed neckband is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 1.25 mL)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

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

  • give 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 6-8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under

6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • do not freeze
  • do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Motrin® Infants’ Drops active ingredient

For Ages 6 to 23 Mos.

INFANTS’ ibuprofen Oral Suspension 50 mg Per 1.25 mL

Pain Reliever Fever Reducer (NSAID)

Lasts up to 8 HOURS

Berry Flavor

Concentrated Drops

No High Fructose Corn Syrup

Use only with enclosed syringe.

1 FL OZ (30 mL)

infants ibuprofen image
infants ibuprofen image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-057IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [MEIJER DISTRIBUTION INC]6Legacy NDC20210925_cf24da4b-69de-43b6-9a84-b474c912ae3f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM3
IBUPROFENACTIVE MOIETYWK2XYI10QM3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SORBITOLINACTIVE INGREDIENT506T60A25R3
SUCROSEINACTIVE INGREDIENTC151H8M5543
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

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
41250-05741250-057-10

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

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 8 · 425 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / TOPICAL34050 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HEMULSION / OPHTHALMIC26 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / RECTAL315 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 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 44.

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
A075217-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16c2088c7a36db…
2026-09-14 22:38:342026-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075217-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL1998-12-163a93d1ddd44b…

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
786ef611-32b5-4070-8fe8-843ecb81fb4ccf24da4b-69de-43b6-9a84-b474c912ae3f2025-12-17WarningsExact identifier
spl set id: cf24da4b-69de-43b6-9a84-b474c912ae3f

Reported adverse events (FAERS/openFDA)#

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