Diurex WaterCaps

Dosage form: tablet, film coated
Ingredients: Caffeine 200mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-613

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each caplet)

Caffeine Anhydrous, 200 mg....................................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
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-613
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Caffeine (Caffeine) Caffeine200 mg
Inactive Ingredients
Ingredient NameStrength
Calcium carbonate 
Calcium sulfate dihydrate 
Starch, corn 
D&C Yellow No. 10 
FD&C Blue No. 1 
FD&C Blue No. 2 
FD&C Red No. 40 
Hypromellose 
Magnesium silicate 
Magnesium stearate 
Mineral oil 
Polyethylene glycol 
Polysorbate 80 
Sodium lauryl sulfate 
Sodium starch glycolate type A potato 
Stearic acid 
Titanium dioxide 
Vanillin 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint CodeALVA
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-613-422 BLISTER PACK (BLISTER PACK) in 1 CARTON
1NDC:52389-613-0121 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35704/15/2009
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010
 
Alva-Amco Pharmacal Companies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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