PROBUFEN

Manufacturer
SAMSUNG PHARM IND. CO., LTD.
Effective date
2012-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:55

Label at a glance#

ProductPROBUFEN
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

Uses 1. Major effects Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain. 2. This can be used also for the following diseases. Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumati...

Dosage and administration

Direction 1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, psoriatic arthritis: 200-600mg per dosage orally, 3~4 times a day as ibuprofen for adults. Maximum dosage is 3200mg per day. 2. Juvenile rheumatoid arthiritis: 30-40mg per kg of body weight divided into 3~4 portions per day orally. 3. Mild and moderate pain, common cold: 200-400mg pe...

Storage and handling

Other informations: Store in a hemetic container. Store between 1C to 30C

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT: Ibuprophen 400mg

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
lactose, microcrystalline cellulose, magnesium stearate, Light Anhydrous Silicic Acid, titanium oxide, Talc, tar colorant, Hypromellose2910, Polyethylene Glycol, Ethanol, Methylene Chloride

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: Pain reliever, Fever Reducer

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Direction
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, psoriatic arthritis:
200-600mg per dosage orally, 3~4 times a day as ibuprofen for adults.
Maximum dosage is 3200mg per day.
2. Juvenile rheumatoid arthiritis:
30-40mg per kg of body weight divided into 3~4 portions per day orally.
3. Mild and moderate pain, common cold:
200-400mg per dosage orally, 3~4 times a day for adults.
Appropriately increase or reduce dosage by age or symptom.
4. Children should take the unit-dose below, 3~4 times a day orally.
The dosage of children weighing less than 30kg should not exceed 500mg per day.
It is advisable to avoid administering on an empty stomach.
Unit-dose for children:
11 - 14 yrs : 200 - 250 mg
7 - 10 yrs : 150 - 200 mg
3 - 6 yrs : 100 - 150 mg
1 - 2 yrs : 50 - 100 mg

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses
1. Major effects
Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain.
2. This can be used also for the following diseases.
Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumatism (tendinitis, tendosynovitis, synovitis)

WARNINGS

WARNINGS SECTION

WARNING
1. When those who drink alcohol over three glasses every day regularly with to take this drug or other antipyretic and analgesic, they must consult a doctor or pharmacist. Gastrointestinal bleeding may occur when these people take this drug.
2. Cardiovascular risks: Administering non-steroidal anti-inflammatory drugs (NSAIDs) including this product may lead to severe cardiovascular thrombotic response, myocardial infaction, and stroke. The possibility of abnormal cardiovascular reaction increases in patients with a period. Adverse reactions should be carefully monitored while an adverse reaction occurs.
3. Gastrointestinal risk: Administering NSAIDs including this product may cause severe gastrointestinal adverse reactions that may develop without any warning signs during the administration period. The risk of these adverse reactions increases in old age (elderly people) or in patients who have taken this drug for a long period.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

STORAGE AND HANDLING SECTION

Other informations:
Store in a hemetic container.
Store between 1C to 30C

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of blister packImage of blister pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197805ibuprofen 400 MG Oral TabletPSN1
197805ibuprofen 400 MG Oral TabletSCD1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
49789-050-012019-11-13C16284748780-197449f38-c644-f6ea-e053-dbdaa90aa7030fabf67c-5046-4272-b49c-17a3a0ba2fc7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49789-050-01PROBUFEN537 mg in 1 BLISTER PACKTABLET5371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49789-050PROBUFEN (IBUPROFEN) TABLET [SAMSUNG PHARM IND. CO., LTD.]1Legacy NDC, 1 package rows20120904_0fabf67c-5046-4272-b49c-17a3a0ba2fc7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM1
IBUPROFENACTIVE MOIETYWK2XYI10QM1
lactoseINACTIVE INGREDIENTJ2B2A4N98G1
magnesium stearateINACTIVE INGREDIENT70097M6I301
Methylene ChlorideINACTIVE INGREDIENT588X2YUY0A1
TalcINACTIVE INGREDIENT7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49789-05049789-050-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 2 · 111 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
lactoseLACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
lactoseLACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
TalcTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates

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
e9ad6a60-d765-4fa6-a155-b7e1e1bfc7330fabf67c-5046-4272-b49c-17a3a0ba2fc72012-09-04WarningsExact identifier
spl id: e9ad6a60-d765-4fa6-a155-b7e1e1bfc733
spl set id: 0fabf67c-5046-4272-b49c-17a3a0ba2fc7

Reported adverse events (FAERS/openFDA)#

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