THROAT COAT SWEET ORANGE FENNEL- menthol lozenge

Throat Coat by

Drug Labeling and Warnings

Throat Coat by is a Otc medication manufactured, distributed, or labeled by Traditional Medicinals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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ACTIVE INGREDIENT

Active ingredient (per drop) Organic menthol 5 mg

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.

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.

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 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.

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.

QUESTIONS

Questions?

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 & 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THROAT COAT  SWEET ORANGE FENNEL
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78732-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 mg  in 4.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LICORICE (UNII: 61ZBX54883)
PECTIN (UNII: 89NA02M4RX)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
FENNEL OIL (UNII: 59AAO5F6HT)
CANOLA OIL (UNII: 331KBJ17RK)
RAW SUGAR (UNII: 8M707QY5GH)
ORANGE OIL (UNII: AKN3KSD11B)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	22mm
Flavor	MENTHOL	Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78732-010-01	16 in 1 POUCH	06/04/2020
1		4.2 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 78732-010-30	30 in 1 POUCH	10/15/2025
2		4.2 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/04/2020

Labeler - Traditional Medicinals, Inc. (107344810)