DIUREX WATER PILLS XPL- caffeine tablet, film coated

Diurex Water Pills by

Drug Labeling and Warnings

Diurex Water Pills by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 retention
• bloat
• swelling
• full feeling
• fatigue

Warnings

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.

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.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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.

QUESTIONS

Questions? 1-800-792-2582

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIUREX WATER PILLS  XPL
caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-406
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	100 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYL VANILLIN (UNII: YC9ST449YJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	green (light green)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-406-18	1 in 1 CARTON	08/17/2016	06/30/2019
1	NDC: 52389-406-02	18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-406-22	1 in 1 CARTON	08/17/2016
2	NDC: 52389-406-01	22 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/17/2016

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)