DIUREX- pamabrom capsule, liquid filled

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 soft gel capsule)

Solubilized pamabrom, 50 mg

Purpose

Diuretic

Uses

For the relief of

• temporary water retention
• 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:  One (1) soft gel capsule after breakfast with a full glass of water.
• Dose may be repeated after 6 hours, not to exceed four (4) soft gel capsules in 24 hours.
• 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.
  

Other information

**Contents sealed:  Each Diurex Aquagel, clear translucent blue colored, oval shaped soft gel capsule 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

FD&C Blue #1, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide.

QUESTIONS

Questions?  1-800-792-2582

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIUREX 
pamabrom capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-136
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (oval soft gel capsule)	Size	8mm
Flavor		Imprint Code	ALVA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-136-20	1 in 1 CARTON	04/15/2013
1	NDC: 52389-136-03	20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-136-40	2 in 1 CARTON	07/17/2019
2		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 52389-136-24	1 in 1 CARTON	09/18/2019
3		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 52389-136-48	2 in 1 CARTON	09/18/2019
4		24 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		04/10/2000

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