Label: FEMALE TONIC- alchemilla vulgaris, asperula odorata, chamomilla, viola odorata, cinchona officinalis, mentha piperita, rosmarinus officinalis, valeriana officinalis, helonia dioica, agnus castus, cimicifuga racemosa, convallaria majalis, crocus sativus, cyclamen europaeum, damiana, hydrastis canadensis, caulophyllum thalictroides, lilium tigrinum, senecio aureus, staphysagria, naja tripudians liquid
- NDC Code(s): 60986-1033-7
- Packager: Marco Pharma International LLC.
- 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 December 6, 2023
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Active Ingredients
Alchemilla Vulgaris 1x
Asperula Odorata 1xHPUS
Chamomilla 1xHPUS
Viola Odorata 1xHPUS
Cinchona Officinalis 2x
Mentha Piperita 1xHPUS
Rosmarinus Officinalis 1xHPUS
Valeriana Officinalis 1xHPUS
Helonias Dioica 2xHPUS
Agnus Castus 3XHPUS
Cimicifuga Racemosa 3xHPUS
Convalleria Majalis 3xHPUS
Crocus Sativus 3xHPUS
Cyclamen Europaeum 3xHPUS
Damiana 3xHPUS
Hydrastis Canadensis 3xHPUS
Caulophyllum Thalictroides 4xHPUS
Lilium Tigrinum 4xHPUS
Senecio Aureus 4xHPUS
Staphysagria 4xHPUS
Naja Tripudians 8xHPUS
The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.
Suggested use
Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEMALE TONIC
alchemilla vulgaris, asperula odorata, chamomilla, viola odorata, cinchona officinalis, mentha piperita, rosmarinus officinalis, valeriana officinalis, helonia dioica, agnus castus, cimicifuga racemosa, convallaria majalis, crocus sativus, cyclamen europaeum, damiana, hydrastis canadensis, caulophyllum thalictroides, lilium tigrinum, senecio aureus, staphysagria, naja tripudians liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60986-1033 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69) (ALCHEMILLA XANTHOCHLORA FLOWERING TOP - UNII:9M289NKI69) ALCHEMILLA XANTHOCHLORA FLOWERING TOP 1 [hp_X] in 100 mL GALIUM ODORATUM (UNII: N8C4A9A49H) (GALIUM ODORATUM - UNII:N8C4A9A49H) GALIUM ODORATUM 1 [hp_X] in 100 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 1 [hp_X] in 100 mL VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA 1 [hp_X] in 100 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 2 [hp_X] in 100 mL MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA 1 [hp_X] in 100 mL ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79) (ROSMARINUS OFFICINALIS FLOWERING TOP - UNII:8JM482TI79) ROSMARINUS OFFICINALIS FLOWERING TOP 1 [hp_X] in 100 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 1 [hp_X] in 100 mL CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 2 [hp_X] in 100 mL CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE 3 [hp_X] in 100 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 3 [hp_X] in 100 mL CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS 3 [hp_X] in 100 mL SAFFRON (UNII: E849G4X5YJ) (SAFFRON - UNII:E849G4X5YJ) SAFFRON 3 [hp_X] in 100 mL CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER 3 [hp_X] in 100 mL TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG 3 [hp_X] in 100 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 3 [hp_X] in 100 mL CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT 4 [hp_X] in 100 mL LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917) (LILIUM LANCIFOLIUM FLOWERING TOP - UNII:6268MFA917) LILIUM LANCIFOLIUM FLOWERING TOP 4 [hp_X] in 100 mL PACKERA AUREA (UNII: 5WS1632J8W) (PACKERA AUREA - UNII:5WS1632J8W) PACKERA AUREA 4 [hp_X] in 100 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 4 [hp_X] in 100 mL NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM 8 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60986-1033-7 236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 02/28/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/1992 Labeler - Marco Pharma International LLC. (161994277) Registrant - Marco Pharma International LLC. (161994277) Establishment Name Address ID/FEI Business Operations Nestmann Pharma GmbH 323426262 manufacture(60986-1033)
