Label: CALM ANXIETY AND STRESS- clematis vitalba, flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, angelica sinensis, argentum nitricum, cacao, lithium carbonicum, prunus cerasifera, flos, valeriana officinalis, piper methysticum, glandula suprarenalis suis, aconitum napellus, anacardium orientale, arsenicum album, calcarea carbonica, cocculus indicus, ignatia amara, gelsemium sempervirens liquid
- NDC Code(s): 70558-0010-1
- Packager: Pro Weight Loss 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 10, 2023
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ACTIVE INGREDIENTS:
Clematis Vitalba, Flos 3X, Helianthemum Nummularium, Flos 3X, Impatiens Glandulifera, Flos 3X, Ornithogalum Umbellatum, Flos 3X, Passiflora Incarnata 3X, Angelica Sinensis 6X, Argentum Nitricum 6X, Cacao 6X, Lithium Carbonicum 6X, Prunus Cerasifera, Flos 6X, Valeriana Officinalis 6X, Piper Methysticum 7X, Glandula Suprarenalis Suis 8X, Aconitum Napellus 12X, Anacardium Orientale 12X, Arsenicum Album 12X, Calcarea Carbonica 12X, Cocculus Indicus 12X, Ignatia Amara 12X, Gelsemium Sempervirens 12X, 30X.
- HOMEOPATHIC INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- HOMEOPATHIC INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
CALM ANXIETY AND STRESS
clematis vitalba, flos, helianthemum nummularium, flos, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, angelica sinensis, argentum nitricum, cacao, lithium carbonicum, prunus cerasifera, flos, valeriana officinalis, piper methysticum, glandula suprarenalis suis, aconitum napellus, anacardium orientale, arsenicum album, calcarea carbonica, cocculus indicus, ignatia amara, gelsemium sempervirens liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70558-0010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER 3 [hp_X] in 1 mL HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER 3 [hp_X] in 1 mL IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER 3 [hp_X] in 1 mL ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B) ORNITHOGALUM UMBELLATUM FLOWERING TOP 3 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 1 mL ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT 6 [hp_X] in 1 mL SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 6 [hp_X] in 1 mL COCOA (UNII: D9108TZ9KG) (COCOA - UNII:D9108TZ9KG) COCOA 6 [hp_X] in 1 mL LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE 6 [hp_X] in 1 mL PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 6 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] in 1 mL MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (MACROPIPER METHYSTICUM ROOT - UNII:BOW48C81XP) MACROPIPER METHYSTICUM ROOT 7 [hp_X] in 1 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 8 [hp_X] in 1 mL ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 12 [hp_X] in 1 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 12 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 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 STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 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:70558-0010-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 07/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/29/2021 Labeler - Pro Weight Loss Inc. (080166665) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(70558-0010) , api manufacture(70558-0010) , label(70558-0010) , pack(70558-0010)
