Label: PMS (angelica archangelica, cimicifuga racemosa, fucus vesiculosus, hypothalamus suis, magnesium gluconicum dihydricum, oophorinum- suis pyridoxinum hydrochloricum, bovista, cuprum metallicum, sepia, zincum metallicum, lachesis mutus liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 43857-0314-1 - Packager: BioActive Nutritional, 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 March 22, 2019
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
PMS
angelica archangelica, cimicifuga racemosa, fucus vesiculosus, hypothalamus suis, magnesium gluconicum dihydricum, oophorinum (suis) pyridoxinum hydrochloricum, bovista, cuprum metallicum, sepia, zincum metallicum, lachesis mutus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0314 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN) ANGELICA ARCHANGELICA ROOT 3 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 3 [hp_X] in 1 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 3 [hp_X] in 1 mL SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS 6 [hp_X] in 1 mL MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE 6 [hp_X] in 1 mL SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 6 [hp_X] in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 6 [hp_X] in 1 mL LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY 12 [hp_X] in 1 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 12 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 15 [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:43857-0314-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/14/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/14/2014 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0314) , api manufacture(43857-0314) , label(43857-0314) , pack(43857-0314)