DIUREX- pamabrom capsule

Diurex by

Drug Labeling and Warnings

Diurex 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 capsule)

Pamabrom, 50 mg

Purpose

Diuretic

Uses

For the relief of

• temporary water weight gain
• bloating
• swelling
• full feeling

associated with the premenstrual and menstrual periods

Warnings

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other medication.

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:  Take one (1) capsule after breakfast with a full glass of water.  Dose may be repeated after six (6) hours, not to exceed four (4) capsules per day.
• Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.
• Drink 6 to 8 glasses of water daily.
• For use by normally healthy adults only.
• Persons under 18 years of age should use only as directed by a doctor.
• Note:  The appearance of golden-tinted urine, which may occur after taking Diurex Water capsules, is a normal and temporary effect.
  

Other Information

**Contents sealed:  Each Diurex Capsule bears the identifying mark "ALVA" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing.  Do not use if seal appears broken or if contents do not match product description.  You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Butyl alcohol, citric acid, FDC Blue #1 Lake, FDC Red #40 Lake, gelatin, magnesium oxide, polysorbate, potassium sorbate, povidone, propylene glycol, riboflavin, shellac, sodium hydroxide, starch, sucrose, talc and titanium dioxide.

QUESTIONS

Questions?  1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIUREX 
pamabrom capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pamabrom (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	Pamabrom	50 mg

Inactive Ingredients
Ingredient Name	Strength
Butyl alcohol (UNII: 8PJ61P6TS3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
Gelatin (UNII: 2G86QN327L)
Magnesium oxide (UNII: 3A3U0GI71G)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Potassium sorbate (UNII: 1VPU26JZZ4)
Povidone (UNII: FZ989GH94E)
Propylene glycol (UNII: 6DC9Q167V3)
Riboflavin (UNII: TLM2976OFR)
Shellac (UNII: 46N107B71O)
Sodium hydroxide (UNII: 55X04QC32I)
Sucrose (UNII: C151H8M554)
Talc (UNII: 7SEV7J4R1U)
Titanium dioxide (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (Clear, colorless capsule containing blue, white and golden beads, sealed closed with a blue band.)	Score	no score
Shape	capsule (Clear number 1 capsule)	Size	19mm
Flavor		Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-325-42	2 in 1 CARTON	10/01/2006
1	NDC: 52389-325-01	21 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-325-21	1 in 1 CARTON	04/01/2005
2	NDC: 52389-325-01	21 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		04/01/2005

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