Label: DIUREX ULTRA- caffeine tablet, film coated

  • NDC Code(s): 52389-155-80
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 15, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient (in each pill)

    Caffeine Anhydrous, 100 mg

  • Purpose

    Diuretic

  • Uses

    For the relief of:

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

    associated with the pre-menstrual and menstrual periods

  • 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 the 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 (100 mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours wile 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

    • Calcium content:  30 mg/pill
    • Identification:  Light green colored, round pill bearing the identifying mark "ALVA".
    • **Contents sealed:  Contents packaged in a bottle with a safety seal under the cap.  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, titanium dioxide.

  • QUESTIONS

    Questions? 1-800-792-2582

  • SPL UNCLASSIFIED SECTION

    Diurex Ultra Spanish Drug Facts

  • PRINCIPAL DISPLAY PANEL

    Diurex Ultra PDP

  • INGREDIENTS AND APPEARANCE
    DIUREX  ULTRA
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-155
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    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)  
    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:52389-155-8080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2005
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)