PROBLEN ESTROGEN AND PROGESTERONE- agnus castus, angelica sinensis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, spray

ProBLEN Estrogen and Progesterone by

Drug Labeling and Warnings

ProBLEN Estrogen and Progesterone by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Agnus castus 3X, Angelica sinensis, radix 3X, Apis mellifica 6X, Arnica montana 6X, Cimicifuga racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium aparine 3X, Glycyrrhiza glabra 3X, Korean ginseng 3X, Oophorinum suis 30C, Progesterone 6X, Sepia 30C, Thuja occidentalis 6X, Viscum album 3X.

PURPOSE

INDICATIONS:  Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

WARNINGS

WARNINGS:   Not for use on children. 

If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician.  Insomnia may be a symptom of a serious underlying medical illness.

As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

DIRECTIONS:  Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day.  Some people notice improvement within two or three weeks, others take longer.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Organic alcohol 30% v/v, Purified water.

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.

INDICATIONS & USAGE

INDICATIONS:  Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

QUESTIONS

Distributed by

ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

PRINCIPAL DISPLAY PANEL

HOMEOPATHIC ORGANOTHERAPY

Estrogen and Progesterone

1.O FL OZ (30ML)

proBLEN

INGREDIENTS AND APPEARANCE

PROBLEN ESTROGEN AND PROGESTERONE 
agnus castus, angelica sinensis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, glycyrrhiza glabra, korean ginseng, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0169
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	3 [hp_X]  in 1 mL
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X]  in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	9 [hp_C]  in 1 mL
ESTRIOL (UNII: FB33469R8E) (ESTRIOL - UNII:FB33469R8E)	ESTRIOL	9 [hp_C]  in 1 mL
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A)	ESTRONE	9 [hp_C]  in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE	3 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	3 [hp_X]  in 1 mL
ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI)	ASIAN GINSENG	3 [hp_X]  in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	30 [hp_C]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)	PROGESTERONE	6 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_X]  in 1 mL
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP)	VISCUM ALBUM FRUITING TOP	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50845-0169-3	1 in 1 CARTON
1	NDC: 50845-0169-2	1 in 1 CARTON
1	NDC: 50845-0169-1	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2012

Labeler - Liddell Laboratories, Inc. (832264241)

Establishment
Name	Address	ID/FEI	Business Operations
Liddell Laboratories, Inc.		832264241	manufacture