MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF

HEXYLRESORCINOL ORAL HUMAN OTC DRUG

MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF is an FDA drug label for the active ingredient HEXYLRESORCINOL manufactured by Reckitt Benckiser LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260831.

Generic name
HEXYLRESORCINOL
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
72854-262
Application
M022
Label effective
20260831

About this product

MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF is an FDA-registered drug product whose active ingredient is HEXYLRESORCINOL. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72854-262, application M022, label effective 20260831. It is one of 3 FDA drug label records sharing the active ingredient HEXYLRESORCINOL. 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.

What it is used for

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

Active ingredients

Active ingredient (in each lozenge) Hexylresorcinol 2 mg

Indications & Usage

Uses temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores

Dosage & Administration

Directions dose as follows or as directed by a doctor or dentist adults and children 12 years of age and older take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 2 hours as needed children under 6 years of age do not use

Warnings

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 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 swelling, rash, or fever develops 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.

More products with the same ingredient

HEXYLRESORCINOL

MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT

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Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions View label

How products containing HEXYLRESORCINOL compare

FDA lists 3 drug label records with HEXYLRESORCINOL 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.

Dosage formProductsManufacturerProducts
— — Reckitt Benckiser LLC 2
— — Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 1
— — — —
— — — —
— — — —

Recall and safety notices

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.

RecallProductFirmClassStatusReported
D-1517-2016 Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 Reckitt Benckiser LLC Class III Terminated 20160928
D-1363-2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Reckitt Benckiser LLC Class I Terminated 20150902
D-1365-2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 Reckitt Benckiser LLC Class I Terminated 20150902
D-1367-2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 Reckitt Benckiser LLC Class I Terminated 20150902
D-1368-2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 Reckitt Benckiser LLC Class I Terminated 20150902

Frequently asked questions

What is MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF used for?
Uses temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores

Who makes MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF?
Reckitt Benckiser LLC is the labeler of record for MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF. 3 FDA label records share the active ingredient HEXYLRESORCINOL, 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 MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF 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 PAIN RELIEF 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 HEXYLRESORCINOL?
Yes. 3 FDA drug label records list HEXYLRESORCINOL 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 MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.