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  5. Label Information: Diurex Water Pills Xpl

FDA Label for Diurex Water Pills Xpl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH PILL)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diurex Water Pills Xpl Product Label

The following document was submitted to the FDA by the labeler of this product Alva-amco Pharmacal Companies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 weight gain
  • bloat
  • swelling
  • full feeling
  • fatigue

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.

Otc - 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.

Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


Otc - Questions



Questions? 1-800-792-2582


* Please review the disclaimer below.