ShopRite Infants Ibuprofen

Manufacturer
Wakefern Food Corporation
Effective date
2019-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:54:56

Label at a glance#

ProductShopRite Infants 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. • 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...

Storage and handling

• store at 20-25°C (68-77°F) • do not freeze • do not use if printed neckband is broken or missing • see bottom of box for lot number and expiration date

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

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, or kidney disease
  • 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
  • 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 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.
  • 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
  • see bottom of box for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, 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-SHOPRITE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Active Ingredient in Motrin® Infants’ Drops

Infants’

FOR AGES 6 TO 23 MOS.

IBUPROFEN

Oral Suspension

50 mg per 1.25 mL

Pain Reliever – Fever Reducer

(NSAID)

LASTS UP TO 8 HOURS

Concentrated Drops

Non-Staining

Dye Free

Gluten Free

No High Fructose Corn Syrup

Berry flavor

Use only with enclosed syringe

1 FL OZ (30 mL)

ShopRite Infants' Ibuprofen Carton Image
ShopRite Infants' Ibuprofen Carton Image

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41190-25541190-255-10

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 · Source PDF

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 · 478 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGRANULE, FOR SUSPENSION / ORAL240 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / ORAL46 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 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
8e3dec18-2ec3-44d1-88e7-bf40a082347b03ea5c2b-9124-466b-965f-6c5b7bcc531b2020-11-30WarningsExact identifier
spl set id: 03ea5c2b-9124-466b-965f-6c5b7bcc531b

Reported adverse events (FAERS/openFDA)#

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