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  5. Label Information: Diurex Max

FDA Label for Diurex Max

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - ASK DOCTOR/PHARMACIST
    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 Max 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 Caplet)



Pamabrom, 50 mg


Purpose




Diuretic


Uses



For the relief of

  • temporary water weight gain
  • bloating
  • swelling
  • full feeling

    • associated with the premenstrual and menstrual periods.


Warnings





Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any other medications.


Otc - Stop Use



Stop use and ask a doctor if symptoms last 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) caplet after breakfast with a full glass of water.
  • Dose may be repeated after 6 hours, not to exceed four (4) caplets in 24 hours.
  • Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.
  • Drink 6 to 8 glasses of water daily.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.

Other Information



Calcium content: 160 mg/caplet.  **Contents sealed:  Each DIUREX Max, light blue colored, oval shaped caplet bears the identifying mark "ALVA"  plus a "1" on the caplet's reverse side 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.  NOTE:  The appearance of golden tinted urine which may occur after taking Diurex Water Caplets is a normal and temporary effect.  You may report serious side effects to the phone number provided under Questions? below.


Inactive Ingredients



Calcium sulfate dihydrate, croscarmellose sodium, dicalcium phosphate, FDC Blue No. 1, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, potassium gluconate, riboflavin, sodium lauryl sulfate, stearic acid and titanium dioxide.


Otc - Questions



Questions?  1-800-792-2582


* Please review the disclaimer below.