Diurex Tablet, Film Coated
FDA Label NDC 52389-249

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Diurex (NDC 52389-249). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.