Drug Facts
.
Throat Coat Lozenge
FDA Label NDC 78732-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Traditional Medicinals, Inc. for the product Throat Coat (NDC 78732-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (per drop) Organic menthol 5 mg
Otc - Purpose
Purposes cough suppressant / oral anesthetic
Indications & Usage
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.
Warnings
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
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.
Otc - Ask Doctor
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
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 worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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 15 mg of potassium.
- Store in a cool, dry place.
- Do not use if the outer wrap is opened or missing.
Inactive Ingredient
Inactive ingredients
Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic cane sugar, water.
Otc - Questions
Questions?
call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F
Other
TRADITIONAL MEDICINALS ®
ORGANIC Throat Coat ®
Soothes Sore Throats & Relieves Coughs
SWEET ORANGE
Cough Suppressant
Oral Anesthetic
16 MENTHOL COUGH DROPS
Distributed by:
Traditional Medicinals
1400 Valley House Dr, Suite 120
Rohnert Park, CA 94928
traditionalmedicinals.com
Certified organic by CCOF
* Please review the disclaimer below.
