Diurex

Manufacturer
Kobayashi Healthcare International, Inc.
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:59:00

Label at a glance#

ProductDiurex Water Pills
Active ingredientMAGNESIUM SALICYLATE, CAFFEINE
Label structure17 sections

Indications and uses

For temporary relief of temporary water retention bloat swelling full feeling fatigue minor aches and pains associated with the premenstrual and menstrual periods.

Dosage and administration

Read all package directions and warnings before use and use only as directed. Adults: Two (2) pills every 4 to 6 hours while symptoms persist, not to exceed eight (8) pills per day. 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...

Label contents#

Full prescribing information#

Active ingredients (in each pill)

OTC - ACTIVE INGREDIENT SECTION

Caffeine, 50 mg

Magnesium Salicylate (NSAID)*, 162.5 mg

(Present as 202 mg of the Tetrahydrate)

*Non-steroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Diuretic

Analgesic (pain reliever)

Uses

INDICATIONS & USAGE SECTION

For temporary relief of

  • temporary water retention
  • bloat
  • swelling
  • full feeling
  • fatigue
  • minor aches and pains

associated with the premenstrual and menstrual periods.

Warnings

WARNINGS SECTION

Reye's Syndrome: Children and teenagers should not use this product for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Magnesium Salicylate may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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.

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug

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 cup of coffee.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts more than 10 days.
  • fever gets worse or lasts more than 3 days.
  • redness or swelling is present.
  • ringing in the ears or loss of hearing occurs.
  • any new symptoms appear.
  • 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.

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 and use only as directed.
  • Adults: Two (2) pills every 4 to 6 hours while symptoms persist, not to exceed eight (8) pills per day.
  • 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.
  • Note: DIUREX Water Pills will not discolor urine.

Other information

INFORMATION FOR PATIENTS SECTION

Magnesium content: 15 mg/pill, Calcium content: 10 mg/pill **Contents sealed: Each DIUREX blue 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, corn starch, crospovidone, FD&C Blue #1 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin.

OTC - QUESTIONS SECTION

Questions?  1-800-792-2582

SPL UNCLASSIFIED SECTION

Diurex Water Pills Spanish Drug FactsDiurex Water Pills Spanish Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1001437caffeine 50 MG / magnesium salicylate 162.5 MG Oral TabletPSN13
1001437caffeine 50 MG / magnesium salicylate 162.5 MG Oral TabletSCD13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
52389-306-01DiurexWater Pills42 in 1 BLISTER PACKTABLET, COATED4213
52389-306-02DiurexWater Pills11 in 1 BLISTER PACKTABLET, COATED1113
52389-306-21DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-21DiurexWater Pills21 in 1 BLISTER PACKTABLET, COATED2113
52389-306-22DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-36DiurexWater Pills2 in 1 CARTONTABLET, COATED213
52389-306-36DiurexWater Pills18 in 1 BLISTER PACKTABLET, COATED1813
52389-306-42DiurexWater Pills1 in 1 CARTONTABLET, COATED113
52389-306-84DiurexWater Pills2 in 1 CARTONTABLET, COATED213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-306DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]13Current NDC, Legacy NDC, 9 package rows20250412_e02a39f9-1c8c-4d38-b394-3f5b7062932c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CaffeineACTIVE INGREDIENT3G6A5W338E2
Magnesium salicylateACTIVE INGREDIENT41728CY7UX2
CaffeineACTIVE MOIETY3G6A5W338E2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
AcaciaINACTIVE INGREDIENT5C5403N26O2
Calcium carbonateINACTIVE INGREDIENTH0G9379FGK2
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
CrospovidoneINACTIVE INGREDIENT68401960MK2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
HypromellosesINACTIVE INGREDIENT3NXW29V3WO2
Magnesium stearateINACTIVE INGREDIENT70097M6I302
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D2
Methylene blueINACTIVE INGREDIENTT42P99266K2
Mineral oilINACTIVE INGREDIENTT5L8T28FGP2
Polyethylene glycol 600INACTIVE INGREDIENTNL4J9F21N92
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H2
ShellacINACTIVE INGREDIENT46N107B71O2
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU42
Sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A22
Starch, cornINACTIVE INGREDIENTO8232NY3SJ2
Stearic acidINACTIVE INGREDIENT4ELV7Z65AP2
TalcINACTIVE INGREDIENT7SEV7J4R1U2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2
TriacetinINACTIVE INGREDIENTXHX3C3X6732

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-30652389-306-01, 52389-306-84, 52389-306-42, 52389-306-02, 52389-306-22, 52389-306-21, 52389-306-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 4 · 184 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE, LIQUID FILLED / ORAL1584 mgExact identifier — unii+route
48 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE / ORAL1742 mgExact identifier — unii+route
48 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Methylene blueMETHYLENE BLUET42P99266KSOLUTION / TOPICAL0.06 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / ORAL650 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
48 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
AcaciaACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE / ORAL1742 mgExact identifier — unii+route
48 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Mineral oilMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
48 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
48 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET / ORAL6 mgExact identifier — unii+route
48 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
48 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
AcaciaACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE, LIQUID FILLED / ORAL1584 mgExact identifier — unii+route
48 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Methylene blueMETHYLENE BLUET42P99266KSOLUTION / TOPICAL0.06 %w/vExact identifier — unii candidate
8 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
AcaciaACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET / ORAL6 mgExact identifier — unii+route
48 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
48 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE, LIQUID FILLED / ORAL1584 mgExact identifier — unii+route
48 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET / ORAL6 mgExact identifier — unii+route
48 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE / ORAL1742 mgExact identifier — unii+route
48 equally ranked IID candidates
Cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TriacetinTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polyethylene glycol 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
48 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
Stearic acidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
8 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 Water PillsCAFFEINE, MAGNESIUM SALICYLATEKobayashi Healthcare International, Inc.e02a39f9-1c8c-4d38-b394-3f5b7062932c2025-04-10WarningsExact identifier
ndc (package): 52389-306-21
ndc (package): 52389-306-02
ndc (package): 52389-306-36
ndc (package): 52389-306-42
ndc (package): 52389-306-22
ndc (package): 52389-306-01
ndc (package): 52389-306-84
ndc (product): 52389-306
ndc11 (package): 52389030602
ndc11 (package): 52389030621
ndc11 (package): 52389030601
ndc11 (package): 52389030636
ndc11 (package): 52389030622
ndc11 (package): 52389030684
ndc11 (package): 52389030642
spl id: 32732994-0e5d-93a9-e063-6394a90a9c50
spl set id: e02a39f9-1c8c-4d38-b394-3f5b7062932c

Reported adverse events (FAERS/openFDA)#

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