FDA.reportPublic FDA data

Diurex

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-04-11
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:59:02

Label at a glance#

ProductDiurex Max
Active ingredientPAMABROM
Label structure12 sections

Indications and uses

For the relief of temporary water retention bloating swelling full feeling associated with the premenstrual and menstrual periods.

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Adults: One (1) pill after breakfast with a full glass of water. Dose may be repeated after 6 hours, not to exceed four (4) pills in 24 hours. Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period. Drink 6 to 8 glasses of water daily. For use by normally healthy adults only. Persons u...

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Pamabrom, 50 mg

Purpose

OTC - PURPOSE SECTION


Diuretic

Uses

INDICATIONS & USAGE SECTION

For the relief of

  • temporary water retention
  • bloating
  • swelling
  • full feeling

associated with the premenstrual and menstrual periods.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other medications.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last more than ten consecutive days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults: One (1) pill after breakfast with a full glass of water.
  • Dose may be repeated after 6 hours, not to exceed four (4) pills in 24 hours.
  • Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.
  • Drink 6 to 8 glasses of water daily.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.

Other information

INFORMATION FOR PATIENTS SECTION

Calcium content: 160 mg/pill. **Contents sealed: Each DIUREX Max, light blue colored, oval shaped pill bears the identifying mark "ALVA" plus a "1" on the pill's reverse side and is sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if product contents do not match product description. NOTE: The appearance of golden tinted urine which may occur after taking Diurex Water Pills is a normal and temporary effect. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium sulfate dihydrate, croscarmellose sodium, dicalcium phosphate, FDC Blue No. 1, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, potassium gluconate, riboflavin, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.

OTC - QUESTIONS SECTION

Questions?  1-800-792-2582

SPL UNCLASSIFIED SECTION

Diurex Max Spanish Drug FactsDiurex Max Spanish Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199158pamabrom 50 MG Oral TabletPSN14
199158pamabrom 50 MG Oral TabletSCD14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-249-10DiurexMax4 in 1 CARTONTABLET, FILM COATED414
52389-249-10DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-16DiurexMax2 in 1 CARTONTABLET, FILM COATED214
52389-249-16DiurexMax8 in 1 BLISTER PACKTABLET, FILM COATED814
52389-249-20DiurexMax30 in 1 BLISTER PACKTABLET, FILM COATED3014
52389-249-20DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-24DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-24DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414
52389-249-30DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-30DiurexMax3 in 1 CARTONTABLET, FILM COATED314
52389-249-40DiurexMax1 in 1 CARTONTABLET, FILM COATED114
52389-249-40DiurexMax40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4014
52389-249-48DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414
52389-249-48DiurexMax2 in 1 CARTONTABLET, FILM COATED214
52389-249-50DiurexMax10 in 1 BLISTER PACKTABLET, FILM COATED1014
52389-249-50DiurexMax5 in 1 CARTONTABLET, FILM COATED514
52389-249-72DiurexMax3 in 1 CARTONTABLET, FILM COATED314
52389-249-72DiurexMax24 in 1 BLISTER PACKTABLET, FILM COATED2414

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-249DIUREX MAX (PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 18 package rows20250413_37dfece3-d570-4ab2-ba95-af6eb1f3acd4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM722
PamabromACTIVE MOIETYUA8U0KJM722
Calcium sulfate dihydrateINACTIVE INGREDIENT4846Q921YM2
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH482
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
HypromelloseINACTIVE INGREDIENT3NXW29V3WO2
Magnesium stearateINACTIVE INGREDIENT70097M6I302
Mineral oilINACTIVE INGREDIENTT5L8T28FGP2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQ2
Potassium gluconateINACTIVE INGREDIENT12H3K5QKN92
RiboflavinINACTIVE INGREDIENTTLM2976OFR2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J2
Stearic acidINACTIVE INGREDIENT4ELV7Z65AP2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-24952389-249-20, 52389-249-40, 52389-249-24, 52389-249-48, 52389-249-16, 52389-249-10, 52389-249-72, 52389-249-30, 52389-249-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POTASSIUM GLUCONATE12H3K5QKN9IACT
CALCIUM SULFATE DIHYDRATE4846Q921YMIACT
RIBOFLAVINTLM2976OFRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PAMABROMUA8U0KJM72ACTIB
TALC7SEV7J4R1UIACT

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 · 120 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
RiboflavinRIBOFLAVINTLM2976OFRTABLET / ORAL0.03 mgExact identifier — unii+route
10 equally ranked IID candidates
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
RiboflavinRIBOFLAVINTLM2976OFRTABLET / ORAL0.03 mgExact identifier — unii+route
10 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
HypromelloseHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Calcium sulfate dihydrateCALCIUM SULFATE DIHYDRATE4846Q921YMTABLET, FILM COATED / ORAL1722 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 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
Diurex MaxPAMABROMKobayashi Healthcare International, Inc.37dfece3-d570-4ab2-ba95-af6eb1f3acd42025-04-11WarningsExact identifier
ndc (package): 52389-249-72
ndc (package): 52389-249-40
ndc (package): 52389-249-20
ndc (package): 52389-249-50
ndc (package): 52389-249-16
ndc (package): 52389-249-30
ndc (package): 52389-249-10
ndc (package): 52389-249-24
ndc (package): 52389-249-48
ndc (product): 52389-249
ndc11 (package): 52389024940
ndc11 (package): 52389024920
ndc11 (package): 52389024924
ndc11 (package): 52389024948
ndc11 (package): 52389024930
ndc11 (package): 52389024972
ndc11 (package): 52389024916
ndc11 (package): 52389024910
ndc11 (package): 52389024950
spl id: 3287c676-c9cc-273e-e063-6294a90a9c9b
spl set id: 37dfece3-d570-4ab2-ba95-af6eb1f3acd4

Reported adverse events (FAERS/openFDA)#

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