Label: MENOPAUSE RELIEF (sanguinaria canadensis, ignatia amara, sepia, adenosinum triphosphoricum dinatrum, bryonia (alba), cedron, dim (3,3-diindolymethane), equol, sulphur, apiolum, lachesis mutus, stannum metallicum, faecalis- alkaligenes liquid
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- NDC Code(s): 43742-0824-1
- 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 October 1, 2018
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- ACTIVE INGREDIENTS:
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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, weight gain, insomnia, weakness, and lack of energy.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
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- 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, weight gain, insomnia, weakness, and lack of energy.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
MENOPAUSE RELIEF
sanguinaria canadensis, ignatia amara, sepia, adenosinum triphosphoricum dinatrum, bryonia (alba), cedron, dim (3,3-diindolymethane), equol, sulphur, apiolum, lachesis mutus, stannum metallicum, faecalis (alkaligenes) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-0824 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 STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 4 [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 BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL SIMABA CEDRON SEED (UNII: KHI40967MV) (SIMABA CEDRON SEED - UNII:KHI40967MV) SIMABA CEDRON SEED 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 APIOLE (PARSLEY) (UNII: QQ67504PXO) (APIOLE (PARSLEY) - UNII:QQ67504PXO) APIOLE (PARSLEY) 6 [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:43742-0824-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/26/2016 06/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/26/2016 06/28/2023 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-0824) , api manufacture(43742-0824) , label(43742-0824) , pack(43742-0824)
