Organic Throat Coat - Sweet Orange Fennel 6 Mg

Organic Throat Coat - Sweet Orange Fennel 6 Mg
SPL v5
SPL
SPL Set ID a746cef4-1fb4-45cf-e053-2995a90a02c8
Route
ORAL
Published
Effective Date 2020-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (6 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 Completed Since 2020-06-04 Until 2028-12-31

Description

Active ingredient (per drop) Organic menthol 6 mg

Purpose

Purposes cough suppressant / oral anesthetic


Medication Information

Purpose

Purposes cough suppressant / oral anesthetic

Description

Active ingredient (per drop) Organic menthol 6 mg

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.
Section 42229-5

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats & Relieves Coughs

SWEET ORANGE FENNEL

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

Section 51945-4

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.

Questions

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

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.
Do Not Use

Do not use:

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

Active ingredient (per drop) Organic menthol 6 mg

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 Ingredients

Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic raw cane sugar, water.

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)
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.
Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

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.
Section 42229-5 (42229-5)

TRADITIONAL MEDICINALS ®

ORGANIC Throat Coat ®

Soothes Sore Throats & Relieves Coughs

SWEET ORANGE FENNEL

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

Section 51945-4 (51945-4)

Purpose

Purposes cough suppressant / oral anesthetic

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.

Questions

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

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.
Do Not Use (Do not use)

Do not use:

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

Active ingredient (per drop) Organic menthol 6 mg

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.
Inactive Ingredients (Inactive ingredients)

Organic fennel oil, organic glucose syrup, organic licorice extract, organic marshmallow extract, organic orange oil, pectin, organic rapeseed oil, organic raw cane sugar, water.

Ask A Doctor Before Use (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)
Stop Use and Ask A Doctor (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.
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


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