ThroatCalm Spray

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:44

Label at a glance#

ProductTHROATCALM
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, PLANTAGO MAJOR WHOLE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (one spray)

Echinacea 1X HPUS (0.01 mL)

Plantago major 1X HPUS (0.01 mL)

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*

Echinacea 1X HPUS (0.01 mL) ... Relieves sore throat pain

Plantago major 1X HPUS (0.01 mL) ... Relieves sore throat pain

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves occasional minor sore throat pain

WARNINGS SECTION

Sore Throat Warning: Severe or persistent 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 12 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

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

Directions

  • Adults and children 12 years of age and older:
  • At the onset of symptoms, apply to the affected area (one spray).
  • Keep in mouth for at least 15 seconds, then swallow.
  • Use up to 6 times a day until symptoms are relieved.
  • Decrease frequency with improvement.
  • Children under 12 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

alcohol, glycerin, L-carvone, purified water

SPL UNCLASSIFIED SECTION

Sore Throat Relief*

Targeted, Soothing Relief

Herbal Mint Flavor

do not use if safety seals are broken or missing, or glued carton end flaps are open

store below 77 o F (25 o C)

retain this carton for full directions

0.68 fl oz

(20 mL)

1 spray per dose
25.2% ALCOHOL

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C, K, CK and X are homeopathic dilutions: see BoironUSA.com/info for details.

OTC - QUESTIONS SECTION

Questions or comments?

BoironUSA.com

Info@Boiron.com

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

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9329-77THROATCALM1 in 1 BOXSPRAY13
0220-9329-77THROATCALM20 mL in 1 BOTTLE, DISPENSINGSPRAY203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9329THROATCALM (ECHINACEA ANGUSTIFOLIA WHOLE, PLANTAGO MAJOR WHOLE) SPRAY [BOIRON]3Current NDC, 2 package rows20241220_f5788da2-f60b-d0b8-e053-2995a90a11c7.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93290220-9329-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
THROATCALMECHINACEA ANGUSTIFOLIA WHOLE, PLANTAGO MAJOR WHOLEBoironf5788da2-f60b-d0b8-e053-2995a90a11c72024-12-18WarningsExact identifier
ndc (package): 0220-9329-77
ndc (product): 0220-9329
ndc11 (package): 00220932977
spl id: 29904ee4-5ece-e1b7-e063-6294a90aba32
spl set id: f5788da2-f60b-d0b8-e053-2995a90a11c7

Reported adverse events (FAERS/openFDA)#

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