Diurex Ultimate

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-06-11 05:11:16

Label at a glance#

ProductDiurex Ultimate
Active ingredientCAFFEINE
Label structure14 sections

Indications and uses

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

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Adults: 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. Drink 6 to 8 glasses of water daily. Recommended for use by normally healthy adults only.

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 the relief of temporary:

  • water retention
  • bloating
  • swelling
  • full feeling
  • fatigue

associated with the premenstrual and menstrual periods.

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 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: 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.
  • 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
  • Identification:  Light green colored, round pill bearing the identifying mark "ALVA".
  • **Contents sealed:  Each DIUREX ULTIMATE pill is sealed in a clear plastic blister with 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 80, stearic acid, titanium dioxide.

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

Spanish Drug Facts Panel

SPL UNCLASSIFIED SECTION

Diurex Ultimate Spanish Drug Facts PanelDiurex Ultimate Spanish Drug Facts Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072959010560GTIN-13: 0072959010560
EAN-13: 0072959010560
GTIN-12: 072959010560
UPC-A: 072959010560
GTIN storage (14 digits): 00072959010560
156-5RC 0824.jpg
Data codeCode 12811560060RC5156-5RC 0824.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
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bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

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
52389-65652389-656-01, 52389-656-60

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-04-14full-release2026-06-01 00:59:11

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 UltimateCAFFEINEKobayashi Healthcare International, Inc.c6debbfe-6061-463f-8f17-fb240c6f1bab2026-06-08WarningsExact identifier
ndc (package): 52389-656-01
ndc (package): 52389-656-60
ndc (product): 52389-656
ndc11 (package): 52389065660
ndc11 (package): 52389065601
spl id: 53c43c3f-7dd9-4887-e063-6294a90a0db4
spl set id: c6debbfe-6061-463f-8f17-fb240c6f1bab

Reported adverse events (FAERS/openFDA)#

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