Label: DIUREX WATERCAPS- caffeine tablet, film coated

  • NDC Code(s): 52389-613-01, 52389-613-42
  • 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 caplet)

    Caffeine Anhydrous, 200 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 or pharmacist 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 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.

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  • 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 (200 mg) every 3 to 4 hours while 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: 180 mg/caplet
    • Identification/product description:  Light green colored, oval caplets bearing the identifying mark "ALVA"
    • **Contents sealed:  Each Diurex caplet is sealed in a clear plastic blister with foil backing.  Do ot use if seal appears broken or if product contents do not match product description.
    • Serious side effects associated with the use of this product may be reported to the phone number provided on the adjacent panel.
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  • INACTIVE INGREDIENT

    Inactive ingredients Calcium carbonate, calcium sulfate, corn starch, DC Yellow No. 10, FDC Blue No. 1, FDC Blue No. 2*, FDC Red No. 40*, Hypromellose, Magnesium silicate*, Magnesium stearate, Mineral oil*, Polyethylene glycol, Polysorbate 80*, Sodium lauryl sulfate*, Sodium starch glycolate*, Stearic acid*, Titanium dioxide* and Vanillin.  *Contains one or more of these ingredients.

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  • QUESTIONS

    Questions?  1-800-792-2582.

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  • INGREDIENTS AND APPEARANCE
    DIUREX  WATERCAPS
    caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-613
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Caffeine (Caffeine) Caffeine 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    Calcium carbonate  
    Calcium sulfate dihydrate  
    Starch, corn  
    D&C Yellow No. 10  
    FD&C Blue No. 1  
    FD&C Blue No. 2  
    FD&C Red No. 40  
    Hypromellose  
    Magnesium silicate  
    Magnesium stearate  
    Mineral oil  
    Polyethylene glycol  
    Polysorbate 80  
    Sodium lauryl sulfate  
    Sodium starch glycolate type A potato  
    Stearic acid  
    Titanium dioxide  
    Vanillin  
    Product Characteristics
    Color green Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code ALVA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-613-42 2 in 1 CARTON
    1 NDC:52389-613-01 21 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part357 04/15/2009
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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