Throatcalm Spray

Throatcalm Spray
SPL v3
SPL
SPL Set ID f5788da2-f60b-d0b8-e053-2995a90a11c7
Route
ORAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia Whole (1 [hp_X]) Plantago Major Whole
Inactive Ingredients
Carvone, (-)- Alcohol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-02-24
Description

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.

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses*

temporarily relieves occasional minor sore throat pain

Dosage and Administration

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.
Description

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.

Section 42229-5

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.

Section 50565-1

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

Section 50567-7

When using this product do not exceed recommended dosage.

Section 51727-6

alcohol, glycerin, L-carvone, purified water

Section 51945-4

Section 53413-1

Questions or comments?

BoironUSA.com

[email protected]

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

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose*

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

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

Section 55106-9

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.

Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves occasional minor sore throat pain

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 51727-6 (51727-6)

alcohol, glycerin, L-carvone, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

BoironUSA.com

[email protected]

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

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

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

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

Section 55106-9 (55106-9)

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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:40.756247 · Updated: 2026-03-14T23:17:05.495474