Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/ Fever Reducer 100 mg/ 5 mL

Manufacturer
Amneal Pharmaceuticals
Effective date
2012-02-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:30:59

Label at a glance#

ProductIbuprofen Pain Reliever/ Fever Reducer
Active ingredientIBUPROFEN
Label structure16 sections

Indications and uses

Temporarily: ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache ■ Reduces fever

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) ■ use only enclosed measuring cup ■ if needed, repeat dose every 6-8 hours ■ do not use more than 4 times a day ■ replace original bottle cap to maintain child resistance Weight (lb) Age (yr) Do...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                               

(in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE

OTC - PURPOSE SECTION

Purpose

Pain reliever/ fever reducer

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses

Temporarily:

  • ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

  • ■ Reduces fever

WARNINGS

WARNINGS SECTION

Warnings

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your child:

  • ■ has had stomach ulcers or bleeding problems

  • ■ takes a blood thinning (anticoagulant) or steroid drug

  • ■ takes other drugs containing an NSAID (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.

OTC - DO NOT USE

OTC - DO NOT USE SECTION

Do not use:

  • ■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer

  • ■ right before or after heart surgery

OTC - ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if:

  • ■ child has problems or serious side effects from taking pain relievers or fever reducers

  • ■ stomach bleeding warning applies to your child

  • ■ child has a history of stomach problems, such as heartburn

  • ■ 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

OTC - ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is:

  • ■ under doctor’s care for any serious condition

  • ■ taking any other drug

OTC - WHEN USING

OTC - WHEN USING SECTION

When using this product:

  • ■ take 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

OTC - STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • ■ 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 the 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

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

  • ■ 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)

  • ■ use only enclosed measuring cup

  • ■ if needed, repeat dose every 6-8 hours

  • ■ do not use more than 4 times a day

  • ■ replace original bottle cap to maintain child resistance

Dosing Chart

Weight (lb) Age (yr)Dose (tsp or mL)
under 2 years ask a doctor
24-35 lbs2-3 years1 tsp or 5 mL
36-47 lbs4-5 years1 ½ tsp or 7.5 mL
48-59 lbs6-8 years2 tsp or 10 mL
60-71 lbs9-10 years2 ½ tsp or 12.5 mL
72-95 lbs11 years3 tsp or 15 mL

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information

  • ■ each teaspoon contains: sodium 2 mg

  • ■ store between 20° to 25°C (68° to 77°F)

  • ■ do not use if bottle wrap, or imprinted foil inner seal is broken or missing

  • ■ see bottom panel for lot number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

acesulfame-potassium, anhydrous citric acid, D&C yellow # 10, FD&C red # 40, glycerin, NA bubble gum flavor FQ5511, polysorbate 80 (tween 80), purified water, sodium benzoate, sucrose, xanthan gum

OTC - QUESTIONS

OTC - QUESTIONS SECTION

Questions or Comments? Call 1-877-835-5472,

Monday through Friday 9AM - 5PM EST.

Keep the carton.

It contains important information.

See end panel for expiration date.

*This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Children’s Motrin®.

SPL UNCLASSIFIED SECTION

Distributed by: Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 07-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

010ab916-figure-01
010ab916-figure-01
010ab916-figure-02
010ab916-figure-02
010ab916-figure-03
010ab916-figure-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN4
197803ibuprofen 20 MG/ML Oral SuspensionSCD4
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY4
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY4

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
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-672-862019-11-13C16284748780-197449f38-b636-f6ea-e053-dbdaa90aa703Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/ Fever Reducer 100 mg/ 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-672-86IbuprofenPain Reliever/ Fever Reducer118 mL in 1 BOTTLESUSPENSION1184
65162-672-86IbuprofenPain Reliever/ Fever Reducer1 in 1 CARTONSUSPENSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-672IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]4Legacy NDC, 2 package rows20120222_ae1cb9ae-9d01-47f0-b9ec-0d924d913514.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM4
IBUPROFENACTIVE MOIETYWK2XYI10QM4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G94
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SUCROSEINACTIVE INGREDIENTC151H8M5544
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

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
65162-67265162-672-86

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 7 · 402 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, ORALLY DISINTEGRATING / ORAL24 mgExact identifier — unii candidate
17 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9FILM / SUBLINGUAL5 mgExact identifier — unii candidate
17 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER / ORAL66 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS81 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SOLUTION / ORAL117 mgExact identifier — unii candidate
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAMUSCULAR25 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER / ORAL48 mgExact identifier — unii candidate
31 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGEL / TOPICAL3 mgExact identifier — unii candidate
61 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAVENOUS1152 mgExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
31 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 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
A200457-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18

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 22:38:342026-08A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200457-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2011-08-186a51e52b5d6a…
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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
010ab916-bc42-4e69-85d6-6585fc34226dae1cb9ae-9d01-47f0-b9ec-0d924d9135142012-02-21WarningsExact identifier
spl id: 010ab916-bc42-4e69-85d6-6585fc34226d
spl set id: ae1cb9ae-9d01-47f0-b9ec-0d924d913514

Reported adverse events (FAERS/openFDA)#

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