Freegells Cough Drops Menthol Eucalyptus

Freegells Cough Drops Menthol Eucalyptus is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Riclan S.A. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71165-012, application M012, label effective 20231026. It is one of 193 FDA drug label records sharing the active ingredient MENTHOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MENTHOL are most often described in connection with: temporarily relieves, cold occasional, minor irritation, sore throat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Directions adults and children 5 years and over dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 5 years ask a doctor

Warnings if sore throat is severe, persists for more than 2 days, is accompained or follwed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promtly. These symptoms may be serious. Sore throat warning: Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompained by excessive phlegm (mucus) Stop use ask doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition. sore throat is severe, or irritation, pain o redness lasts or worsens sore mouth does not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

FDA lists 193 drug label records with MENTHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Freegells Cough Drops Menthol Eucalyptus used for?
Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat

Who makes Freegells Cough Drops Menthol Eucalyptus?
Riclan S.A. is the labeler of record for Freegells Cough Drops Menthol Eucalyptus. 193 FDA label records share the active ingredient MENTHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Freegells Cough Drops Menthol Eucalyptus come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Freegells Cough Drops Menthol Eucalyptus prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MENTHOL?
Yes. 193 FDA drug label records list MENTHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Freegells Cough Drops Menthol Eucalyptus been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.