Throat Coat
Organic Throat Coat - Eucalyptus Mint
a7a86f1b-30e8-6f5d-e053-2a95a90a2a82
HUMAN OTC DRUG LABEL
Sep 25, 2025
Traditional Medicinals, Inc.
DUNS: 107344810
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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.
SPL UNCLASSIFIED SECTION
TRADITIONAL MEDICINALS ®
ORGANIC Throat Coat ®
Soothes Sore Throats & Relieves Coughs
EUCALYPTUS MINT
Cough Suppressant
Oral Anesthetic
16 MENTHOL COUGH DROPS
Manufactured for:
Traditional Medicinals
1400 Valley House Dr, Suite 120
Rohnert Park, CA 94928
Product of Switzerland
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Active ingredient (per drop) Organic menthol 6 mg
OTC - PURPOSE SECTION
Purpose
Purposes cough suppressant / oral anesthetic
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
Do not use
Do not use:
- If you are allergic to any of the ingredients.
- Manufactured in a facility that also handles coconut oil
OTC - ASK DOCTOR SECTION
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)
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
- Each lozenge contains 10 mg of potassium.
- Store in a cool, dry place.
- Do not use if the outer wrap is opened or missing.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Organic eucalyptus oil, organic glulcose syrup, organic ivy extract, pectin, organic peppermint oil, organic rapeseed oil, organic raw cane sugar, water.
OTC - QUESTIONS SECTION
Questions
call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F