FDA.reportPublic FDA data

Diurex Water Pills

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:40:25

Label at a glance#

ProductDiurex Water Pills XPL
Active ingredientCAFFEINE
Label structure14 sections

Indications and uses

For relief of symptoms associated with the premenstrual and menstrual periods including: temporary water retention bloat swelling full feeling fatigue

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Adults:  One (1) pill (100mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period. Start taking 5 or 6 days before onset of period and continue use until desired relief is obtained or end of period. Drink 6 to 8 glasses of water daily. Recommended for use by normall...

Label contents#

Full prescribing information#

Active ingredient (in each pill)

OTC - ACTIVE INGREDIENT SECTION

Caffeine Anhydrous, 100 mg

Purpose

OTC - PURPOSE SECTION

Diuretic

Uses

INDICATIONS & USAGE SECTION

For relief of symptoms associated with the premenstrual and menstrual periods including:

  • temporary water retention
  • bloat
  • swelling
  • full feeling
  • fatigue

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • taking any other medications
  • under 18 years of age.  Do not give to children under 12 years of age.

OTC - WHEN USING SECTION

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause:

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heart beat. The recommended dose of this product contains about as much caffeine as one to two cups of coffee.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last for 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 (100mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period.
  • Start taking 5 or 6 days before onset of period and continue use until desired relief is obtained or end of period.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.

Other information

INFORMATION FOR PATIENTS SECTION

  • Calcium content:  30 mg/pill
  • **Contents sealed:  Each DIUREX light green colored, round shaped pill bears the identifying mark "ALVA" 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.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, calcium carbonate, croscarmellose sodium, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate, stearic acid and titanium dioxide.

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

SPL UNCLASSIFIED SECTION

DiurexXPL Spanish Drug FactsDiurexXPL Spanish Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diurex XPL PDPDiurex XPL PDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072959060220GTIN-13: 0072959060220
EAN-13: 0072959060220
GTIN-12: 072959060220
UPC-A: 072959060220
GTIN storage (14 digits): 00072959060220		DiurexXPLR17.jpg
Data codeCode 128106022RC17DiurexXPLR17.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-406-01Diurex Water PillsXPL22 in 1 BLISTER PACKTABLET, FILM COATED2211
52389-406-02Diurex Water PillsXPL18 in 1 BLISTER PACKTABLET, FILM COATED1811
52389-406-18Diurex Water PillsXPL1 in 1 CARTONTABLET, FILM COATED111
52389-406-22Diurex Water PillsXPL1 in 1 CARTONTABLET, FILM COATED111

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-40652389-406-02, 52389-406-18, 52389-406-01, 52389-406-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ETHYL VANILLINYC9ST449YJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ACACIA5C5403N26OIACT
HYPROMELLOSES3NXW29V3WOIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 806OZP39ZG8HIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-05-09full-release2026-06-01 00:12:18

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
41af3013-45df-d34a-e063-6294a90ab4659f971b95-47f4-4bd4-beec-2296b4c9cbdc2025-10-21WarningsExact identifier
spl id: 41af3013-45df-d34a-e063-6294a90ab465
spl set id: 9f971b95-47f4-4bd4-beec-2296b4c9cbdc

Reported adverse events (FAERS/openFDA)#

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