FDA.reportPublic FDA data

Throat Coat

Manufacturer
Traditional Medicinals, Inc.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:22

Label at a glance#

ProductThroat Coat Lemon Ginger Echinacea
Active ingredientPECTIN
Label structure13 sections

Indications and uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per drop) Pectin 5 mg

Purpose

OTC - PURPOSE SECTION

Purpose oral demulcent

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

WARNINGS SECTION

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days see your dentist or doctor promptly.

Do not use

OTC - DO NOT USE SECTION

Do not use:

  • If you are allergic to any of the ingredients.
  • Manufactured in a facility that also handles coconut oil

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Sore mouth does not improve in 7 days
  • irritation, pain, or redness persistst or worsesns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 SAFETY INFORMATION

  • Each lozenge contains 20 mg of potassium.
  • Store in a cool, dry place.
  • Do not use if the outer wrap is opened or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, organic echinacea extract, organic ginger extract, organic glucose syrup, organic lemon oil, organic rapeseed oil, organic raw cane sugar, water.

Questions

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats

LEMON GINGER ECHINACEA

Oral Demulcent

16 PECTIN THROAT DROPS

Distributed by:

Traditional Medicinals

1400 Valley House Dr, Suite 120

Rohnert Park, CA 94928

www.TraditionalMedicinals.com

Certified organic by CCOF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78732-100-00Throat CoatLemon Ginger Echinacea2 in 1 POUCHLOZENGE24
78732-100-00Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24
78732-100-01Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24
78732-100-01Throat CoatLemon Ginger Echinacea16 in 1 POUCHLOZENGE164
78732-100-30Throat CoatLemon Ginger Echinacea30 in 1 POUCHLOZENGE304
78732-100-30Throat CoatLemon Ginger Echinacea4.2 g in 1 PACKAGELOZENGE4.24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78732-10078732-100-01, 78732-100-30, 78732-100-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CANOLA OIL331KBJ17RKIACT
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
RAW SUGAR8M707QY5GHIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
LEMON OILI9GRO824LLIACT
GINGERC5529G5JPQIACT

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
Throat Coat Lemon Ginger EchinaceaPECTINTraditional Medicinals, Inc.a7a92a52-9ace-66d1-e053-2a95a90a8d8e2025-11-21WarningsExact identifier
ndc (package): 78732-100-00
ndc (package): 78732-100-01
ndc (package): 78732-100-30
ndc (product): 78732-100
ndc11 (package): 78732010000
ndc11 (package): 78732010001
ndc11 (package): 78732010030
spl id: 44f86312-ab4d-44ba-e063-6294a90a9f40
spl set id: a7a92a52-9ace-66d1-e053-2a95a90a8d8e

Reported adverse events (FAERS/openFDA)#

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