Motrin IB

Manufacturer
Kenvue Brands LLC
Effective date
2025-10-03
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:15:52

Label at a glance#

ProductMotrin IB
Active ingredientIBUPROFEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

read all warnings and directions before use store between 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning

SPL UNCLASSIFIED SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • if you have 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

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

  • do not take more than directed
  • the smallest effective dose should be used
adults and children 12 years and older:
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years:
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • read all warnings and directions before use
  • store between 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-230-07

Motrin ®IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever / Fever Reducer (NSAID)

Actual Size

24 Coated Caplets**

**Capsule-Shaped Tablets

motrin-01motrin-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN15
201126Motrin IB 200 MG Oral TabletPSN15
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD15
310965ibuprofen 200 MG Oral TabletSCD15
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY15
201126Motrin 200 MG Oral TabletSY15

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
50580-230-01Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-01Motrin IB50 in 1 BOTTLETABLET, FILM COATED5015
50580-230-02Motrin IB60 in 1 BOTTLETABLET, FILM COATED6015
50580-230-02Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-03Motrin IB100 in 1 BOTTLETABLET, FILM COATED10015
50580-230-03Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB225 in 1 BOTTLETABLET, FILM COATED22515
50580-230-05Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-05Motrin IB300 in 1 BOTTLETABLET, FILM COATED30015
50580-230-06Motrin IB500 in 1 BOTTLETABLET, FILM COATED50015
50580-230-06Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB24 in 1 BOTTLETABLET, FILM COATED2415
50580-230-08Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB50 in 1 CARTONTABLET, FILM COATED5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-230-01EA - Each50580-230cc8f08de-0241-475b-a545-b0a755cb1af312018-04-19
50580-230-02EA - Each50580-230b0995e76-9209-4ee6-a3df-52dac753035112017-03-06
50580-230-03EA - Each50580-2309b1cf925-49e6-4fc4-8bc0-5214192c4f8312018-05-09
50580-230-04EA - Each50580-2307762e942-27c6-4845-ad02-dd99aa0860c012024-04-05
50580-230-06EA - Each50580-23087541607-8b7c-4ea4-bab2-4e4d9200867012016-12-07
50580-230-07EA - Each50580-230ce62c3eb-301b-4537-9973-a909356d679012023-12-05
50580-230-09EA - Each50580-2302ceccfbe-9a6a-44b6-a475-80dde15586a512024-04-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
A077349-001IBUPROFENIBUPROFEN200MGTABLET / ORALRS2005-06-21

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 22:38:342026-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21f41ea6bd6efb…

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
Motrin IBIBUPROFENKenvue Brands LLCd21129f8-4d96-4e36-bc39-a534306dd77e2025-10-03WarningsExact identifier
ndc (package): 50580-230-08
ndc (package): 50580-230-06
ndc (package): 50580-230-04
ndc (package): 50580-230-09
ndc (package): 50580-230-07
ndc (package): 50580-230-03
ndc (package): 50580-230-01
ndc (package): 50580-230-05
ndc (package): 50580-230-02
ndc (product): 50580-230
ndc11 (package): 50580023007
ndc11 (package): 50580023003
ndc11 (package): 50580023009
ndc11 (package): 50580023005
ndc11 (package): 50580023002
ndc11 (package): 50580023008
ndc11 (package): 50580023004
ndc11 (package): 50580023001
ndc11 (package): 50580023006
spl id: 4003a46c-d99c-72f4-e063-6394a90ab2db
spl set id: d21129f8-4d96-4e36-bc39-a534306dd77e

Reported adverse events (FAERS/openFDA)#

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