Ibuprofen

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:32:46

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

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

store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each white caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 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
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • 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)
  • skin reddening
  • shock
  • 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

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.

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

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
    • weakness in one part or side of body
    • leg swelling
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area

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 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: 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

  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality
+
Plus

NDC 50844-353-16

†Compare to active ingredient
in Motrin® IB Caplets

IBUPROFEN
TABLETS
USP, 200 mg

PAIN RELIEVER/FEVER REDUCER
(NSAID)

1000 Coated Caplets**
(**CAPSULE-SHAPED TABLETS)

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Motrin® IB
Caplets.                                       50844            REV1221C35316

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Quality Plus 44-353
Quality Plus 44-353

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN13
310965ibuprofen 200 MG Oral TabletSCD13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050844353169GTIN-13: 0050844353169
EAN-13: 0050844353169
GTIN-12: 050844353169
UPC-A: 050844353169
GTIN storage (14 digits): 00050844353169
quality-plus-44-353-1.jpg

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
50844-353-02Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1213
50844-353-02Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
50844-353-16Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QM1
IbuprofenACTIVE MOIETYWK2XYI10QM1
HypromelloseINACTIVE INGREDIENT3NXW29V3WO1
LactoseINACTIVE INGREDIENTJ2B2A4N98G1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
PolydextroseINACTIVE INGREDIENTVH2XOU12IE1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1A1
PovidoneINACTIVE INGREDIENTFZ989GH94E1
Starch, CornINACTIVE INGREDIENTO8232NY3SJ1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
TriacetinINACTIVE INGREDIENTXHX3C3X6731

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-35350844-353-02, 50844-353-16

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

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 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PolydextrosePOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PovidonePOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PovidonePOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LactoseLACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LactoseLACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PovidonePOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LactoseLACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PolydextrosePOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PolydextrosePOLYDEXTROSEVH2XOU12IETABLET, FILM COATED / ORAL18 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 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
A075139-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

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 22:38:342026-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075139-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…

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
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsExact identifier
ndc (package): 50844-353-16
ndc (package): 50844-353-02
ndc (product): 50844-353
ndc11 (package): 50844035316
ndc11 (package): 50844035302
spl id: 5f8c5841-a57f-4394-bbc2-93fc48474282
spl set id: c93da67f-f42e-4baa-976b-73c71ba6dd71

Reported adverse events (FAERS/openFDA)#

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