VoiceCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:38:04

Label at a glance#

ProductVoiceCalm
Active ingredientARISAEMA TRIPHYLLUM ROOT, FERROSOFERRIC PHOSPHATE, ARNICA MONTANA WHOLE, TOXICODENDRON PUBESCENS LEAF, SPONGIA OFFICINALIS SKELETON, ROASTED, CALCIUM SULFIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Arnica montana 9C HPUS (0.07 mg)

Arum triphyllum 9C HPUS (0.07 mg)

Ferrum phosphoricum 9C HPUS (0.07 mg)

Hepar sulphuris calcareum 30C HPUS (0.07 mg)

Rhus tox 9C HPUS (0.07 mg)

Spongia tosta 9C HPUS (0.07 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*

Relieves Hoarseness, Loss of Voice, and Occasional Minor Throat Irritation

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves:

  • hoarseness
  • loss of voice associated with vocal strain
  • occasional minor throat irritation

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 or administer to children under 6 years of age 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 and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every hour, up to 6 times per day. Reduce frequency with improvement.
  • Children under 6 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

  • do not use if glued carton end flaps are open or pellet dispenser seal is broken
  • contains 0.25 g sugar per dose

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

VOCAL STRAIN RELIEF*

  • Relieves Without Numbing
  • No Water Needed

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Turn tube upside down & twist cap.

*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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9331-41VoiceCalm80 in 1 TUBEPELLET802
0220-9331-42VoiceCalm2 in 1 CARTONPELLET22

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93310220-9331-41, 0220-9331-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
VoiceCalmARNICA MONTANA WHOLE, ARISAEMA TRIPHYLLUM ROOT, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, TOXICODENDRON PUBESCENS LEAF, SPONGIA OFFICINALIS SKELETON, ROASTEDBoiron4b6fce7b-8a2e-b318-e063-6394a90ac2112026-03-20WarningsExact identifier
ndc (package): 0220-9331-42
ndc (package): 0220-9331-41
ndc (product): 0220-9331
ndc11 (package): 00220933142
ndc11 (package): 00220933141
spl id: 4d7724d7-b82a-a525-e063-6394a90a417e
spl set id: 4b6fce7b-8a2e-b318-e063-6394a90ac211

Reported adverse events (FAERS/openFDA)#

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