Diurex Water Pills
FDA Label NDC 52389-406

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 Water Pills (NDC 52389-406). 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 pill), purpose, uses, ask a doctor before use if, otc - when using, 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 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.