Label: HOMEOPATHIC CALM DROPS- arsenic trioxide 30c, matricaria chamomilla12x, arabica coffee bean 30x, potassium carbonate30c, strychnos ignatii seed30x, lachesis muta venom12x, phosphoric acid 3x, anemone pulsatilla 12c, valerian 30c, aconitum napellus 6x, chloride ion 12x, strychnos nux-vomica seed 30c lozenge
- NDC Code(s): 57556-006-01
- Packager: HISTORICAL REMEDIES LLP.
- 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 31, 2024
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Indications
For temporary relief of occasional anxiety, tension and irritability. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, Ignatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.
Equal volumes of each ingredient.
- PURPOSE
- Directions
- Warnings
- Active ingredients
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
HOMEOPATHIC CALM DROPS
arsenic trioxide 30c, matricaria chamomilla12x, arabica coffee bean 30x, potassium carbonate30c, strychnos ignatii seed30x, lachesis muta venom12x, phosphoric acid 3x, anemone pulsatilla 12c, valerian 30c, aconitum napellus 6x, chloride ion 12x, strychnos nux-vomica seed 30c lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57556-006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 12 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_X] POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 30 [hp_C] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 3 [hp_X] PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 12 [hp_C] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 30 [hp_C] ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 6 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] Inactive Ingredients Ingredient Name Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) ACHLYS TRIPHYLLA WHOLE (UNII: 91THU5EJ2I) Product Characteristics Color white Score no score Shape ROUND Size 14mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57556-006-01 30 in 1 BOX; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2020 Labeler - HISTORICAL REMEDIES LLP. (627758634)