Diurex WaterCaps: Package Insert and Label Information

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

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.

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 PDP
(click image for full-size original)

DIUREX WATERCAPS
caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Caffeine (Caffeine) Caffeine 200 mg
Inactive Ingredients
Ingredient Name Strength
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
Color green Score no score
Shape OVAL Size 15mm
Flavor Imprint Code ALVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52389-613-42 2 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK (52389-613-01)
1 NDC:52389-613-01 21 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (52389-613-42)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part357 04/15/2009
Labeler — Alva-Amco Pharmacal Companies, Inc. (042074856)

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

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