Label: DIUREX WATER PILLS XPL- caffeine tablet, film coated

  • NDC Code(s): 52389-406-01, 52389-406-02, 52389-406-18, 52389-406-22
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each pill)

    Caffeine Anhydrous, 100 mg

  • Purpose

    Diuretic

  • Uses

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

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

  • Ask a doctor before use if

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

    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.
  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.

  • Directions

    • 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

    • 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

    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.

  • QUESTIONS

    Questions? 1-800-792-2582

  • SPL UNCLASSIFIED SECTION

    DiurexXPL Spanish Drug Facts

  • PRINCIPAL DISPLAY PANEL

    Diurex XPL PDP

  • INGREDIENTS AND APPEARANCE
    DIUREX WATER PILLS  XPL
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ACACIA (UNII: 5C5403N26O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorgreen (light green) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ALVA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-406-181 in 1 CARTON08/17/201606/30/2019
    1NDC:52389-406-0218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-406-221 in 1 CARTON08/17/2016
    2NDC:52389-406-0122 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02708/17/2016
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)