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: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/10

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

  • Active ingredient (in each pill)

    Caffeine Anhydrous, 100 mg.......................................Diuretic

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  • Uses

    For relief of

    • temporary water weight gain
    • bloat
    • swelling
    • full feeling
    • fatigue
    associated with the premenstrual and menstrual periods.
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  • 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.
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  • 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. Close
  • STOP USE

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

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.
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  • Directions

    • Read all package directions and warnings before use.
    • Use only as directed.
    • Adults:  One pill (100 mg) or two pills (200 mg) every 3 to 4 hours wile symptoms persist.
    • Drink 6 to 8 glasses of water daily.
    • Recommended for use by normally healthy adults only.
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  • Other information

    • Calcium content:  90 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.
    • Serious side effects associated with this product may be reported to the phone number provided below.
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  • 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.

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  • QUESTIONS

    Questions? 1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    DIUREX  ULTRA
    caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-155
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Caffeine (Caffeine) Caffeine 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    Acacia  
    Calcium carbonate  
    Croscarmellose sodium  
    Ethyl vanillin  
    D&C YELLOW NO. 10  
    FD&C Blue No. 1  
    FD&C Blue No. 2  
    Hypromellose  
    Magnesium silicate  
    Magnesium stearate  
    Maltodextrin  
    Cellulose, microcrystalline  
    Polyethylene glycol 600  
    Polysorbate 80  
    Stearic acid  
    Titanium dioxide  
    Lactose  
    Product Characteristics
    Color green (light green) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code ALVA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-155-80 80 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part357 09/01/2005
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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