Label: PROBLEN ESTROGEN AND PROGESTERONE- agnus castus, angelica sinesis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50845-0138-1, 50845-0138-2, 50845-0138-3 - Packager: Liddell Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 6, 2012
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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 bovinum 30C, Progesterone 6X, Sepia 30C, Thuja occidentalis 6X, Viscum album 3X.
- PURPOSE
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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.
TAMPER EVIDENT: There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROBLEN ESTROGEN AND PROGESTERONE
agnus castus, angelica sinesis, radix, apis mellifica, arnica montana, cimicifuga racemosa, estradiol, estriol, folliculinum, galium aparine, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0138 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 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 BOS TAURUS OVARY (UNII: 66LZN1C747) (BOS TAURUS OVARY - UNII:66LZN1C747) BOS TAURUS OVARY 30 [hp_C] 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:50845-0138-3 1 in 1 CARTON 1 NDC:50845-0138-2 1 in 1 CARTON 1 NDC:50845-0138-1 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/21/2010 Labeler - Liddell Laboratories, Inc. (832264241) Establishment Name Address ID/FEI Business Operations Liddell Laboratories, Inc. 832264241 manufacture