Mucinex® INSTASOOTHE™ Sore Throat Winter Fresh

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:57:25

Label at a glance#

ProductMucinex Insta soothe Sore Throat Winter Fresh
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 6 years of age and older: apply to affected area (one spray); gargle, swish around in the mouth, or allow to remain in place at least 1 minute then spit out. Use up to 4 times daily or as directed by a doctor or dentist. Children 6 to under 12 years of age SUPERVISE USE Children under 6 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves occasional minor irritation and pain associated with
■ sore throat

■ sore mouth
■ canker sores

Warnings

WARNINGS SECTION

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

■ pale, gray, or blue colored skin (cyanosis)
■ headache

■ rapid heart rate
■ shortness of breath
■ dizziness or lightheadedness
■ fatigue or lack of energy

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics.

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
■ for teething

■ 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • apply to affected area (one spray); gargle, swish around in the mouth, or allow to remain in place at least 1 minute then spit out. Use up to 4 times daily or as directed by a doctor or dentist. Children 6 to under 12 years of age SUPERVISE USE

Children under 6 years of age:

  • do not use

Other Infomation

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, cetylpyridinium chloride, dibasic sodium phosphate, edetate disodium, flavor, hydrochloric acid*, polyethylene glycol, propylene glycol, purified water, sodium hydroxide*, sucralose
*may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
©2023 RB Health
Made in Canada
www.mucinex.com

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 72854-266-04

Mucinex® INSTASOOTHE™

Benzocaine 5.0mg oral pain reliever

Menthol 2.0mg oral pain reliever

✔ Numbs Pain Fast
✔ Maximum Cool

Product Label

Front LabelFront Label

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637856benzocaine 5 % / menthol 2 % Mucosal SprayPSN4
2637856benzocaine 50 MG/ML / menthol 20 MG/ML Mucosal SpraySCD4
2637856benzocaine 5 % / menthol 2 % Mucosal SpraySY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824996790GTIN-13: 0363824996790
EAN-13: 0363824996790
GTIN-12: 363824996790
UPC-A: 363824996790
GTIN storage (14 digits): 00363824996790
Mucinex Instasoothe Winterfresh Back Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-266-04Mucinex Insta sootheSore Throat Winter Fresh115 mL in 1 BOTTLE, SPRAYSPRAY1154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-266-04ML - Milliliter72854-2660c1923b3-9958-479c-9d25-f995e5ced9f912024-03-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-26672854-266-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-23monthly-update2026-06-03 17:46:38

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
51b68560-44a8-af68-e063-6294a90afa03f7a6ed6d-2b71-b9a2-e053-6394a90a04ef2026-05-13WarningsExact identifier
spl id: 51b68560-44a8-af68-e063-6294a90afa03
spl set id: f7a6ed6d-2b71-b9a2-e053-6394a90a04ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.