THROATCALM

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:20:01

Label at a glance#

ProductTHROATCALM
Active ingredientARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, ARNICA MONTANA
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

Purpose*

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

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves minor sore throat and hoarseness

OTC - ASK DOCTOR SECTION

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.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 SECTION

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.

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9327-41THROATCALM80 in 1 TUBEPELLET802
0220-9327-42THROATCALM2 in 1 BOXPELLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9327THROATCALM (ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, BROMINE, BRYONIA ALBA ROOT, ARNICA MONTANA, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) PELLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20230202_de97d002-de84-bcef-e053-2995a90a319b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93270220-9327-41, 0220-9327-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THROATCALMARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, MERCURIUS SOLUBILIS, BROMINE, BRYONIA ALBA ROOT, ARNICA MONTANA, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTEDBoironde97d002-de84-bcef-e053-2995a90a319b2023-01-31Exact identifier
ndc (package): 0220-9327-41
ndc (package): 0220-9327-42
ndc (product): 0220-9327
ndc11 (package): 00220932742
ndc11 (package): 00220932741
spl id: f396a5be-36bb-d582-e053-2a95a90affaa
spl set id: de97d002-de84-bcef-e053-2995a90a319b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.