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

  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Purpose*

    Relieves Sore Throat Symptoms: Red and Dry Throat, Raw Sore Throat, Hoarseness, Swollen Tonsils

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves minor sore throat and hoarseness

  • WARNINGS

  • ASK DOCTOR

    Ask a doctor before use:

    • in children under 3 years of age
    • if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.
  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Adults and children 3 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, take 5 pellets every 6 hours. Decrease frequency with improvement.
  • INACTIVE INGREDIENT

    lactose, sucrose

  • 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

    BoironUSA.com

    Info@Boiron.com

    1-800-264-7661

    Made in France

    Distributed by

    Boiron Inc.

    Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • 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 pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9327
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT3 [hp_C]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_C]
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS4 [hp_C]
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE3 [hp_C]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_C]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_C]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9327-422 in 1 BOX05/09/2022
    1NDC:0220-9327-4180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9327)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!