Label: THROATCALM- arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted tablet
- NDC Code(s): 0220-9325-04, 0220-9325-29
- Packager: Laboratoires Boiron
- 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 May 2, 2023
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Active Ingredients
Active ingredients** (in each tablet)
Arnica montana 3C HPUS (0.28 mg)**
Arum triphyllum 3C HPUS (0.28 mg)**
Belladonna 3C HPUS (0.28 mg)** (contains less than 10 -8 mg atropine alkaloids)
Bromium 3C HPUS (0.28 mg)** (contains less than 10 -6 mg bromine)
Bryonia 3C HPUS (0.28 mg)**
Mercurius solubilis 4C HPUS (0.28 mg)** (contains less than 10 -8 mg mercury)
Phytolacca decandra 3C HPUS (0.28 mg)**
Pulsatilla 3C HPUS (0.28 mg)**
Spongia tosta 3C HPUS (0.28 mg)**
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
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Purpose
Arnica montana 3C HPUS ... Relieves hoarseness due to overexertion of the vocal cords*
Arum triphyllum 3C HPUS ... Relieves vocal cord fatigue in speakers and singers*
Belladonna 3C HPUS ... Relieves red and sore throat*
Bromium 3C HPUS ... Relieves swollen and painful tonsils*
Bryonia alba 3C HPUS ... Relieves sore throat with intense thirst*
Mercuris solubilis 4C HPUS ... Relieves sore throat with intense salivation*
Phytolacca decandra 3C HPUS ... Relieves sore throat with pain spreading to the ears*
Pulsatilla 3C HPUS ... Relieves raw sore throat*
Spongia tosta 3C HPUS ... Relieves hoarseness with dry throat* - Uses
- WARNINGS
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Directions
Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, take 2 tablets every 6 hours. Decrease frequency with improvement.
Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above. - Other information
- Inactive Ingredient
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Sore Throat Relief*
Red, Dry,and Sore Throat Hoarseness*
Relieves Pain Without Numbing*
For Ages 4+ Years
No Aftertaste
60 Meltaway tablets unflavored
120 Meltawat tablets unflavored
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details. - Principle Display Panel - ThroatCalm
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INGREDIENTS AND APPEARANCE
THROATCALM
arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9325 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C] ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT 3 [hp_C] BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI) BELLADONNA LEAF 3 [hp_C] BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 3 [hp_C] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_C] SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_C] MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 4 [hp_C] PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_C] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 3 [hp_C] Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND (BOIRON) Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9325-04 60 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/01/2017 2 NDC:0220-9325-29 120 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2017 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9325)
