Drugplain

Throat Coat Sweet Orange Fennel 5 mg/4.2g

Menthol · LOZENGE · Traditional Medicinals, Inc.

No Recall History
Plain English

Throat Coat Sweet Orange Fennel is a lozenge containing menthol at 5 mg/4.2g, taken oral. Manufactured by Traditional Medicinals, Inc..

Key Facts

Brand Name
Throat Coat Sweet Orange Fennel
Generic Name
Menthol
NDC Code (Product)
78732-010
Manufacturer
Traditional Medicinals, Inc.
Strength
5 mg/4.2g
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/04/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use92 reports
drug ineffective82 reports
dyspnoea82 reports
fatigue81 reports
pain75 reports
pruritus72 reports
dizziness65 reports
cough64 reports
headache63 reports
drug hypersensitivity58 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

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.

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.

Frequently Asked Questions

What is Throat Coat Sweet Orange Fennel used for?

Throat Coat Sweet Orange Fennel contains Menthol. It is a lozenge taken oral. Consult your doctor for specific uses.

Is Throat Coat Sweet Orange Fennel a controlled substance?

Throat Coat Sweet Orange Fennel is not classified as a controlled substance by the DEA.

What is the generic name for Throat Coat Sweet Orange Fennel?

The generic name for Throat Coat Sweet Orange Fennel is Menthol. There are 12 other brand versions of Menthol.

What is the NDC code for Throat Coat Sweet Orange Fennel 5 mg/4.2g?

The NDC (National Drug Code) for Throat Coat Sweet Orange Fennel 5 mg/4.2g is 78732-010, listed by Traditional Medicinals, Inc..