Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)

Manufacturer
Strategic Sourcing Services | AptaPharma Inc.
Effective date
2025-02-20
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:12

Label at a glance#

ProductIbuprofen Oral
Active ingredientIBUPROFEN
Label structure15 sections

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 ■ mL = milliliter ■ find right dose on chart. If possible, use weight to dose; otherwise use age. ■ use only enclosed dosing cup. Do not use any other dosing device. ■ if needed, repeat dose every 6-8 hours ■ do not use more than 4 times a day ■ replace original bottle cap to mai...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION


Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION


Pain reliever/ fever reducer

USE(S)

INDICATIONS & USAGE SECTION


temporarily:
■ relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
■ reduces fever

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

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 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


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)

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
■ mL = milliliter
■ find right dose on chart. If possible, use weight to dose; otherwise use age.
■ use only enclosed dosing cup. Do not use any other dosing device.
■ 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 (mL)*
Weight (lb) Age (yr) Dose (mL)*
Weight (lb) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
under 24 under 2 years ask a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
24-35 lbs 2-3 years 5 mL
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
36-47 lbs 4-5 years 7.5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
48-59 lbs 6-8 years 10 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
60-71 lbs 9-10 years 12.5 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL
72-95 lbs 11 years 15 mL
72-95 lbs 11 years 15 mL

*or as directed by a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION


■ each 5 mL contains : sodium 2 mg
■ store between 20-25°C (68-77°F)
■ do not use if carton is opened or printed bottle neckband is broken or missing
■ see bottom panel for lot number and expiration date

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION


Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow # 10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

QUESTIONS or COMMENTS?

SPL UNCLASSIFIED SECTION


Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST


©2023 McKesson Corporation
Distributed by: McKesson Corp., via Strategic Sourcing Services LLC.
Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com

** This product is not manufactured or distributed by McNeil
Consumer Healthcare, distributor of Children’s Motrin®.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ibuprofen-oral-suspension-berry-flavor-container-carton-118 mL

ibuprofen-oral-suspension-berry-flavor-container-carton1
ibuprofen-oral-suspension-berry-flavor-container-carton1

ibuprofen-oral-suspension-berry-original-flavor-container-carton-237 mL

ibuprofen-oral-suspension-berry-original-flavor-container-carton2.
ibuprofen-oral-suspension-berry-original-flavor-container-carton2.

ibuprofen-oral-suspension-bubble-gum-flavor-container-carton-118 mL

ibuprofen-oral-suspension-bubble-gum-flavor-container-carton3.ibuprofen-oral-suspension-bubble-gum-flavor-container-carton3.


ibuprofen-oral-suspension-grape-flavor-container-carton-118 mL

ibuprofen-oral-suspension-grape-flavor-container-carton4.ibuprofen-oral-suspension-grape-flavor-container-carton4.

ibuprofen-oral-suspension-original-berry-flavor-container-carton-118 mL

ibuprofen-oral-suspension-original-berry-flavor-container-carton5.ibuprofen-oral-suspension-original-berry-flavor-container-carton5.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN3
197803ibuprofen 20 MG/ML Oral SuspensionSCD3
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY3
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1115-1Ibuprofen Oral1 in 1 CARTONSUSPENSION13
70677-1115-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1183
70677-1115-2Ibuprofen Oral1 in 1 CARTONSUSPENSION13
70677-1115-2Ibuprofen Oral237 mL in 1 BOTTLESUSPENSION2373
70677-1116-1Ibuprofen Oral1 in 1 CARTONSUSPENSION13
70677-1116-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1183
70677-1117-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1183
70677-1117-1Ibuprofen Oral1 in 1 CARTONSUSPENSION13
70677-1118-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1183
70677-1118-1Ibuprofen Oral1 in 1 CARTONSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1115IBUPROFEN ORAL SUSPENSION [STRATEGIC SOURCING SERVICES]3Current NDC, 4 package rows20250316_863f7ce3-b7b9-4c66-b351-5b95dd23dcb4.zip
70677-1116IBUPROFEN ORAL SUSPENSION [STRATEGIC SOURCING SERVICES]3Current NDC, 2 package rows20250316_863f7ce3-b7b9-4c66-b351-5b95dd23dcb4.zip
70677-1117IBUPROFEN ORAL SUSPENSION [STRATEGIC SOURCING SERVICES]3Current NDC, 2 package rows20250316_863f7ce3-b7b9-4c66-b351-5b95dd23dcb4.zip
70677-1118IBUPROFEN ORAL SUSPENSION [STRATEGIC SOURCING SERVICES]3Current NDC, 2 package rows20250316_863f7ce3-b7b9-4c66-b351-5b95dd23dcb4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1115-1ML - Milliliter70677-1115193cf120-b3be-40e8-b252-7dd66514217912023-09-05
70677-1115-2ML - Milliliter70677-1115bf93d723-604c-4e72-9717-44e30648a66812023-09-05
70677-1116-1ML - Milliliter70677-1116bb0f2588-747e-4ceb-b3d1-7df13a11468112023-09-05
70677-1117-1ML - Milliliter70677-1117fb8ccb04-b552-4f58-9b16-d6806ec9ecbd12023-09-05
70677-1118-1ML - Milliliter70677-111808881bb5-f76d-4d5d-9dad-c6ebc387888512023-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 54 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 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
A210602-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23

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
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2026-09-14 22:38:342026-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f01610625f2…
2019-09-15 20:21 UTC2019-09A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210602-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2018-11-233a93d1ddd44b…

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
Ibuprofen OralIBUPROFEN ORALStrategic Sourcing Services863f7ce3-b7b9-4c66-b351-5b95dd23dcb42025-02-20WarningsExact identifier
ndc (package): 70677-1116-1
ndc (package): 70677-1115-1
ndc (package): 70677-1115-2
ndc (package): 70677-1117-1
ndc (package): 70677-1118-1
ndc (product): 70677-1116
ndc (product): 70677-1118
ndc (product): 70677-1115
ndc (product): 70677-1117
ndc11 (package): 70677111801
ndc11 (package): 70677111701
ndc11 (package): 70677111501
ndc11 (package): 70677111601
ndc11 (package): 70677111502
spl id: 19df0c73-0b7d-481c-b3c4-63baeef064f6
spl set id: 863f7ce3-b7b9-4c66-b351-5b95dd23dcb4

Reported adverse events (FAERS/openFDA)#

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