MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE

MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE is an FDA-registered drug product whose active ingredient is HEXYLRESORCINOL AND MENTHOL. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-268, application M012, label effective 20260901. 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 HEXYLRESORCINOL AND MENTHOL are most often described in connection with: temporarily relieves, occasional minor, pain due, sore mouth, canker sores, bronchial irritation, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves: ■ occasional minor irritation and pain due to a sore mouth or sore throat ■ pain associated with canker sores ■ cough due to minor throat and bronchial irritation as may occur with the common cold

Directions ■ adults and children 6 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. ■ children under 6 years of age: do not use

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not use in children under 6 years of age When using this product do not exceed recommended dosage Ask a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor or dentist if ■ sore mouth symptoms do not improve in 7 days ■ irritation, pain, or redness persists or worsens ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE used for?
Uses temporarily relieves: ■ occasional minor irritation and pain due to a sore mouth or sore throat ■ pain associated with canker sores ■ cough due to minor throat and bronchial irritation as may occur with the common cold

Who makes MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE?
Reckitt Benckiser LLC is the labeler of record for MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE.

What form does MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE 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 MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE 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.

Has MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.