Organic Throat Coat - Sweet Orange Fennel 5 Mg

Organic Throat Coat - Sweet Orange Fennel 5 Mg
SPL v1
SPL
SPL Set ID 4538248f-11cc-d6b2-e063-6294a90a652c
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 (5 mg)
Inactive Ingredients
Water Licorice Pectin Althaea Officinalis Root Fennel Oil Canola Oil Raw Sugar Orange Oil Corn Syrup

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

Description

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Medication Information

Warnings and Precautions

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.

Indications and 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.
Dosage and 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.
Description

.

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.
Section 50569-3

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)
Section 50570-1

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.
Section 51727-6

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.

Section 51945-4

Section 53413-1

Questions?

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

Section 55105-1

Purposes cough suppressant / oral anesthetic

Section 55106-9

Active ingredient (per drop) Organic menthol 5 mg

Drug Facts

.

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.

Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.
Section 50569-3 (50569-3)

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)
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Purposes cough suppressant / oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (per drop) Organic menthol 5 mg

Drug Facts

.

Other Information (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.

Advanced Ingredient Data


Raw Label Data

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