Motrin IB

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2019-11-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:55:32

Label at a glance#

ProductMotrin IB
Active ingredientIBUPROFEN
Label structure8 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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

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

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 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

Do not use

OTC - DO NOT USE SECTION

• if you have 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

• 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, or kidney disease
• you have asthma
• 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
• 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

• 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
• 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

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

SPL UNCLASSIFIED SECTION

• store between 20-25ºC (68-77ºF)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, hypromellose, iron oxide, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Motrin IBMotrin IB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-165-012023-03-16C16284748780-1f386c64a-160b-0266-e053-dadaa90a7c1aMotrin IB
67751-165-022023-03-16C16284748780-1f386c64a-160b-0266-e053-dadaa90a7c1aMotrin IB
67751-165-012023-01-30C16284748780-1f386c64a-160b-0266-e053-dadaa90a7c1aMotrin IB
67751-165-022023-01-30C16284748780-1f386c64a-160b-0266-e053-dadaa90a7c1aMotrin IB

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-110-01EA - Each50580-110867365d4-4425-426f-bf59-46f6dfabd14b12012-07-24
50580-110-02EA - Each50580-11031401772-7c9b-4d71-a279-1ec4a77f095212012-07-24
50580-110-03EA - Each50580-110914bf222-d4b9-4d69-bcff-2e30fd34d5f612012-07-24
50580-110-09EA - Each50580-1101589ab72-c436-43bf-bf25-c883ae326ea212012-07-24
50580-110-19EA - Each50580-11070e17cab-9b09-4dd3-833f-5acdbedda78b12012-07-24
50580-110-37EA - Each50580-11087af4730-f4f3-48ea-a65f-b5c15c0e194c12012-07-24
50580-110-52EA - Each50580-11082dfca75-6914-4194-8717-ea1fd3354c1b12012-07-24
50580-110-60EA - Each50580-1106ea6daa9-b107-4f42-b767-9b0336899dfd12012-07-24
50580-110-62EA - Each50580-1102b192ee9-708a-4776-96db-60c8310b4b8412012-07-24
50580-110-64EA - Each50580-11062c27713-706d-4be9-b73c-34d7ffc2095512012-07-24
50580-110-95EA - Each50580-110d939130b-4e12-4684-a078-d07ccdbfba5212012-07-24

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-16567751-165-01, 67751-165-02
50580-110

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

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019012-001NUPRINIBUPROFEN200MGTABLET / ORAL1984-05-18
N019012-002NUPRINIBUPROFEN200MGTABLET / ORAL1987-07-29
N019012-003MOTRIN IBIBUPROFEN200MGTABLET / ORALRLD1990-12-17
N019012-004MOTRIN MIGRAINE PAINIBUPROFEN200MGTABLET / ORAL2000-02-25

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019012-001NUPRIN200MGTABLET / ORAL1984-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N019012-002NUPRIN200MGTABLET / ORAL1987-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2584e616aacf4f…
2026-08-18 06:07:402026-07N019012-001NUPRIN200MGTABLET / ORAL1984-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-002NUPRIN200MGTABLET / ORAL1987-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019012-001NUPRIN200MGTABLET / ORAL1984-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-002NUPRIN200MGTABLET / ORAL1987-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-001NUPRIN200MGTABLET / ORAL1984-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-002NUPRIN200MGTABLET / ORAL1987-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019012-001NUPRIN200MGTABLET / ORAL1984-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-002NUPRIN200MGTABLET / ORAL1987-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-001NUPRIN200MGTABLET / ORAL1984-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-002NUPRIN200MGTABLET / ORAL1987-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-001NUPRIN200MGTABLET / ORAL1984-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-002NUPRIN200MGTABLET / ORAL1987-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-001NUPRIN200MGTABLET / ORAL1984-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-002NUPRIN200MGTABLET / ORAL1987-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-001NUPRIN200MGTABLET / ORAL1984-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-002NUPRIN200MGTABLET / ORAL1987-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-001NUPRIN200MGTABLET / ORAL1984-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-002NUPRIN200MGTABLET / ORAL1987-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-003MOTRIN IB200MGTABLET / ORALRLD1990-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019012-004MOTRIN MIGRAINE PAIN200MGTABLET / ORAL2000-02-255bbf6a4d5a75…

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
f70b4446-281d-47c9-e053-6294a90aaa5db0a87ef4-eef7-459d-9842-6d4e5a08227f2023-03-16WarningsExact identifier
spl set id: b0a87ef4-eef7-459d-9842-6d4e5a08227f

Reported adverse events (FAERS/openFDA)#

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