Label: PMS RELIEF (agnus castus, cimicifuga racemosa, kali carbonicum, lycopodium clavatum, saccharum officinale, thyroidinum (bovine), hypothalamus suis, aristolochia clematitis, folliculinum, aurum sulphuratum, candida albicans, cocculus indicus, conium maculatum, cyclamen europaeum, elaps corallinus, lac caninum, lachesis mutus, magnesia carbonica, pulsatilla- pratensis, stannum metallicum liquid
- NDC Code(s): 43742-1342-1
- 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 January 15, 2024
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ACTIVE INGREDIENTS:
Agnus Castus 6X, Cimicifuga Racemosa 6X, Kali Carbonicum 6X, Lycopodium Clavatum 6X, Saccharum Officinale 6X, Thyroidinum (Bovine) 6X, 12X, 30X, Hypothalamus Suis 8X, Aristolochia Clematitis 9X, Folliculinum 10X, 12X, 30X, Aurum Sulphuratum 12X, Candida Albicans 12X, 30X, Cocculus Indicus 12X, Conium Maculatum 12X, Cyclamen Europaeum 12X, Elaps Corallinus 12X, Lac Caninum 12X, Lachesis Mutus 12X, Magnesia Carbonica 12X, Pulsatilla (Pratensis) 12X, Stannum Metallicum 12X.
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to premenstrual syndrome, such as mood swings, irritability, anger, sadness, weeping, anxiety, acne, bowel congestion, head pain, muscle pain before menses.**
**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 the temporary relief of symptoms related to premenstrual syndrome, such as mood swings, irritability, anger, sadness, weeping, anxiety, acne, bowel congestion, head pain, muscle pain before menses.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
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INGREDIENTS AND APPEARANCE
PMS RELIEF
agnus castus, cimicifuga racemosa, kali carbonicum, lycopodium clavatum, saccharum officinale, thyroidinum (bovine), hypothalamus suis, aristolochia clematitis, folliculinum, aurum sulphuratum, candida albicans, cocculus indicus, conium maculatum, cyclamen europaeum, elaps corallinus, lac caninum, lachesis mutus, magnesia carbonica, pulsatilla (pratensis), stannum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1342 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE FRUIT - UNII:433OSF3U8A) CHASTE TREE FRUIT 6 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 6 [hp_X] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 6 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] in 1 mL SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE 6 [hp_X] in 1 mL THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE 6 [hp_X] in 1 mL SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS 8 [hp_X] in 1 mL ARISTOLOCHIA CLEMATITIS ROOT (UNII: ZY0NX0W00D) (ARISTOLOCHIA CLEMATITIS ROOT - UNII:ZY0NX0W00D) ARISTOLOCHIA CLEMATITIS ROOT 9 [hp_X] in 1 mL ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE 10 [hp_X] in 1 mL GOLD MONOSULFIDE (UNII: 03VC3O9F7W) (GOLD CATION (1+) - UNII:3D8CUH9F21, SULFIDE ION - UNII:G15I91XETI) GOLD MONOSULFIDE 12 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 12 [hp_X] in 1 mL ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 12 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 12 [hp_X] in 1 mL CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER 12 [hp_X] in 1 mL MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM 12 [hp_X] in 1 mL CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK 12 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] in 1 mL MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 12 [hp_X] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 12 [hp_X] in 1 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 12 [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:43742-1342-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/10/2018 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1342) , api manufacture(43742-1342) , label(43742-1342) , pack(43742-1342)
