Label: MENOPAUSE RELIEF (sanguinaria canadensis, sepia, adenosinum triphosphoricum dinatrum, dim (3, 3-diindolymethane), equol, sulphur, petroselinum sativum, bryonia (alba), ignatia amara, cedron, lachesis mutus, stannum metallicum, faecalis- alkaligenes liquid
- NDC Code(s): 43742-1590-1
- Packager: Deseret Biologicals, 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 August 14, 2024
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ACTIVE INGREDIENTS:
Sanguinaria Canadensis 3X, Sepia 4X, Adenosinum Triphosphoricum Dinatrum 6X, DIM (3,3’-Diindolymethane) 6X, Equol 6X, Sulphur 6X, Petroselinum Sativum 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Bryonia (Alba) 8X, Ignatia Amara 8X, Cedron 11X, Lachesis Mutus 12X, Stannum Metallicum 12X, Faecalis (Alkaligenes) 30C.
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to hormone fluctuations associated with menopause, including hot flashes, mood swings, night sweats, flushing, headache, weakness, and lack of energy.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration. - WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to hormone fluctuations associated with menopause, including hot flashes, mood swings, night sweats, flushing, headache, weakness, and lack of energy.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration. - INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
MENOPAUSE RELIEF
sanguinaria canadensis, sepia, adenosinum triphosphoricum dinatrum, dim (3, 3-diindolymethane), equol, sulphur, petroselinum sativum, bryonia (alba), ignatia amara, cedron, lachesis mutus, stannum metallicum, faecalis (alkaligenes) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1590 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 3 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 4 [hp_X] in 1 mL ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM 6 [hp_X] in 1 mL 3,3'-DIINDOLYLMETHANE (UNII: SSZ9HQT61Z) (3,3'-DIINDOLYLMETHANE - UNII:SSZ9HQT61Z) 3,3'-DIINDOLYLMETHANE 6 [hp_X] in 1 mL EQUOL, (-)- (UNII: 2T6D2HPX7Q) (EQUOL, (-)- - UNII:2T6D2HPX7Q) EQUOL, (-)- 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 1 mL PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 8 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 8 [hp_X] in 1 mL SIMABA CEDRON SEED (UNII: KHI40967MV) (SIMABA CEDRON SEED - UNII:KHI40967MV) SIMABA CEDRON SEED 11 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] in 1 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 12 [hp_X] in 1 mL ALCALIGENES FAECALIS (UNII: 05KB30NGW2) (ALCALIGENES FAECALIS - UNII:05KB30NGW2) ALCALIGENES FAECALIS 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:43742-1590-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 11/14/2019 12/05/2028 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/14/2019 12/05/2028 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1590) , api manufacture(43742-1590) , label(43742-1590) , pack(43742-1590)