Label: THROATCALM- arisaema triphyllum root, atropa belladonna, mercurius solubilis, bromine, bryonia alba root, arnica montana, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted pellet
- NDC Code(s): 0220-9327-41, 0220-9327-42
- Packager: 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 January 31, 2023
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient** (in each pellet)
Arnica montana 3C HPUS (0.05 mg)
Arum triphyllum 3C HPUS (0.05 mg)
Belladonna 3C HPUS (0.05 mg) (contains less than 10-9 mg atropine alkaloids)
Bromium 3C HPUS (0.05 mg) (contains less than 10-7 mg bromine)
Bryonia 3C HPUS (0.05 mg)
Mercurius solubilis 4C HPUS (0.05 mg) (contains less than 10-9 mg mercury)
Phytolacca decandra 3C HPUS (0.05 mg)
Pulsatilla 3C HPUS (0.05 mg)
Spongia tosta 3C HPUS (0.05 mg)
The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia on the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if pellet dispenser seal is broken
- contains 0.25 g of sugar per dose
Sore Throat Relief*
Relieves Pain Without Numbing*
No Aftertaste
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Contains approx. 80 pellets, 3.8 g (0.13 oz)
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and pour pellets under the tongue
Do not use if pellet dispenser seal is broken,
*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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THROATCALM
arisaema triphyllum root, atropa belladonna, mercurius solubilis, bromine, bryonia alba root, arnica montana, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9327 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT 3 [hp_C] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_C] MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 4 [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] 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] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9327-42 2 in 1 BOX 05/09/2022 1 NDC:0220-9327-41 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/09/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9327)