DIUREX WATERCAPS- caffeine tablet, film coated 
Alva-Amco Pharmacal Companies, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Diurex Water Caps

Active ingredient (in each caplet)

Caffeine Anhydrous, 200 mg

Purpose

Diuretic

Uses

For relief of

  • temporary water weight gain
  • bloat
  • swelling
  • full feeling
  • fatigue

associated with the premenstrual and menstrual periods.

Warnings


Ask a doctor or pharmacist before use if

  • taking any other medications
  • under 18 years of age.  Do not give to children under 12 years of age.

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 two cups of coffee.

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

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

Keep out of the 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 pill (200 mg) every 3 to 4 hours while symptoms persist.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.

Other information

  • Calcium content: 180 mg/caplet
  • Identification/product description:  Light green colored, oval caplets bearing the identifying mark "ALVA"
  • **Contents sealed:  Each Diurex caplet is sealed in a clear plastic blister with foil backing.  Do ot use if seal appears broken or if product contents do not match product description.
  • Serious side effects associated with the use of this product may be reported to the phone number provided on the adjacent panel.

Inactive ingredients Calcium carbonate, calcium sulfate, corn starch, DC Yellow No. 10, FDC Blue No. 1, FDC Blue No. 2*, FDC Red No. 40*, Hypromellose, Magnesium silicate*, Magnesium stearate, Mineral oil*, Polyethylene glycol, Polysorbate 80*, Sodium lauryl sulfate*, Sodium starch glycolate*, Stearic acid*, Titanium dioxide* and Vanillin.  *Contains one or more of these ingredients.

Questions?  1-800-792-2582.

Diurex WaterCaps PDP

DIUREX  WATERCAPS
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-613
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
VANILLIN (UNII: CHI530446X)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-613-422 in 1 CARTON04/15/200911/30/2016
1NDC:52389-613-0121 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/200911/30/2016
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 4/2019
 
Alva-Amco Pharmacal Companies, Inc.