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  5. Label Information: Diurex

FDA Label for Diurex

View Indications, Usage & Precautions

Table of Contents

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

Diurex 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 Capsule)



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


Otc - Ask Doctor/Pharmacist



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


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:  Take one (1) capsule after breakfast with a full glass of water.  Dose may be repeated after six (6) hours, not to exceed four (4) capsules per day.
  • 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.
  • Note:  The appearance of golden-tinted urine, which may occur after taking Diurex Water capsules, is a normal and temporary effect.

Other Information



**Contents sealed:  Each Diurex Capsule bears the identifying mark "ALVA" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing.  Do not use if seal appears broken or if contents do not match product description.  You may report serious side effects to the phone number provided under Questions? below.


Inactive Ingredients



Butyl alcohol, citric acid, FDC Blue #1 Lake, FDC Red #40 Lake, gelatin, magnesium oxide, polysorbate, potassium sorbate, povidone, propylene glycol, riboflavin, shellac, sodium hydroxide, starch, sucrose, talc and titanium dioxide.


Otc - Questions



Questions?  1-800-792-2582


* Please review the disclaimer below.