organic throat coat - eucalyptus mint

organic throat coat - eucalyptus mint
SPL v4
SPL
SPL Set ID a7a86f1b-30e8-6f5d-e053-2a95a90a2a82
Route
oral
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (6 mg)
Inactive Ingredients
peppermint oil canola oil corn syrup pectin water raw sugar eucalyptus oil hedera helix leaf

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: oval Color: brown Size: 22 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-06-04

Purpose

Purposes cough suppressant / oral anesthetic

Description

Active ingredient (per drop) Organic menthol 6 mg


Medication Information

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.

Uses

Temporarily relieves

  • Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants.
  • Occasional minor irritaions, pain, sore mouth, and sore throat.
Purpose

Purposes cough suppressant / oral anesthetic

Directions
  • Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day
  • Children under 12 years of age: ask a doctor.
Other Information
  • Each lozenge contains 5 mg of potassium.
  • Store in a cool, dry place.
  • Do not use if the outer wrap is opened or missing.
Inactive Ingredients

Organic eucalyptus oil, organic glulcose syrup, organic ivy extract, pectin, organic peppermint oil, organic rapeseed oil, organic raw cane sugar, water.

Description

Active ingredient (per drop) Organic menthol 6 mg

Section 42229-5

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats & Relieves Coughs

EUCALYPTUS MINT

Cough Suppressant

Oral Anesthetic

30 MENTHOL COUGH DROPS

Distributed by:

Traditional Medicinals

1400 Valley House Dr, Suite 120

Rohnert Park, CA 94928

traditionalmedicinals.com

Certified organic by CCOF

Section 51945-4

Questions

call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F

Do Not Use

Do not use:

  • If you are allergic to any of the ingredients.
  • Produced in a facility that also processes almonds, coconuts, pecans, peanuts, soy, and milk products
Active Ingredient

Active ingredient (per drop) Organic menthol 6 mg

Ask A Doctor Before Use

Ask a doctor before use if you have:

  • A persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
  • Cough accopanied by excessive phlegm (mucus)
Stop Use and Ask A Doctor

Stop use and ask a doctor if:

  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent heacache. This could be the sign of a sereious condition.
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting.
  • Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persistst or worsesns.
Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.

Uses

Temporarily relieves

  • Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants.
  • Occasional minor irritaions, pain, sore mouth, and sore throat.
Purpose

Purposes cough suppressant / oral anesthetic

Directions
  • Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day
  • Children under 12 years of age: ask a doctor.
Other Information (Other information)
  • Each lozenge contains 5 mg of potassium.
  • Store in a cool, dry place.
  • Do not use if the outer wrap is opened or missing.
Inactive Ingredients (Inactive ingredients)

Organic eucalyptus oil, organic glulcose syrup, organic ivy extract, pectin, organic peppermint oil, organic rapeseed oil, organic raw cane sugar, water.

Section 42229-5 (42229-5)

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats & Relieves Coughs

EUCALYPTUS MINT

Cough Suppressant

Oral Anesthetic

30 MENTHOL COUGH DROPS

Distributed by:

Traditional Medicinals

1400 Valley House Dr, Suite 120

Rohnert Park, CA 94928

traditionalmedicinals.com

Certified organic by CCOF

Section 51945-4 (51945-4)

Questions

call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F

Do Not Use (Do not use)

Do not use:

  • If you are allergic to any of the ingredients.
  • Produced in a facility that also processes almonds, coconuts, pecans, peanuts, soy, and milk products
Active Ingredient (Active ingredient)

Active ingredient (per drop) Organic menthol 6 mg

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if you have:

  • A persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
  • Cough accopanied by excessive phlegm (mucus)
Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if:

  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent heacache. This could be the sign of a sereious condition.
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting.
  • Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persistst or worsesns.
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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