ThroatCalm 18+ Tablets

Manufacturer
Boiron | Boiron, Inc.
Effective date
2026-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:37:37

Label at a glance#

ProductThroatCalm
Active ingredientSPONGIA OFFICINALIS SKELETON, ROASTED, BROMINE, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, ARNICA MONTANA, PHYTOLACCA AMERICANA ROOT, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BRYONIA ALBA ROOT
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

Purpose*

Arnica montana 3C HPUS (0.28 mg)……..……Relieves hoarseness due to overexertion of the vocal cords

Arum triphyllum 3C HPUS (0.28 mg).…………….………..Relieves vocal cord fatigue in speakers and singers

Belladonna 3C HPUS (0.28 mg) ……………………....………………………………………..Relieves red and sore throat

Bromium 3C HPUS (0.28 mg)…………….………………………………………..…Relieves swollen and painful tonsils

Bryonia 3C HPUS (0.28 mg)….…………..…………………………………..…Relieves sore throat with intense thirst

Mercurius solubilis 4C HPUS (0.28 mg)…………………………..…Relieves sore throat with intense salivation

Phytolacca decandra 3C HPUS (0.28 mg)………….…Relieves sore throat with pain spreading to the ears

Pulsatilla 3C HPUS (0.28 mg)………………...………………..………………….……..………....Relieves raw sore throat

Spongia tosta 3C HPUS (0.28 mg)……………………..…….…………………..Relieves hoarseness with dry throat

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves occasional minor sore throat and hoarseness

WARNINGS SECTION

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets in the mouth every 6 hours. Decrease frequency with improvement.

SPL UNCLASSIFIED SECTION

Other information

  • do not use if glued carton end flaps are open or if the blister seal is broken
  • store below 86°F (30°C)
  • retain carton for full drug facts

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

SORE THROAT RELIEF*

Red, Dry, and Sore Throat

Hoarseness*

  • Relieves Pain Without Numbing*
  • No Aftertaste

60 Meltaway Tablets

*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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

LABELLABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130306969284049GTIN-13: 0306969284049
EAN-13: 0306969284049
GTIN-12: 306969284049
UPC-A: 306969284049
GTIN storage (14 digits): 00306969284049
ThroatCalm ETU.1L5W 0226.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9284-04ThroatCalm20 in 1 BLISTER PACKTABLET201
0220-9284-04ThroatCalm3 in 1 CARTONTABLET31

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-92840220-9284-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
ThroatCalmARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, ATROPA BELLADONNA, BROMINE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS WHOLEBoiron4ae45fc7-c0f4-3770-e063-6394a90ac80e2026-02-15WarningsExact identifier
ndc (package): 0220-9284-04
ndc (product): 0220-9284
ndc11 (package): 00220928404
spl id: 4ae45fc7-c0f5-3770-e063-6394a90ac80e
spl set id: 4ae45fc7-c0f4-3770-e063-6394a90ac80e

Reported adverse events (FAERS/openFDA)#

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