MUCINEX® INSTASOOTHE®

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-03 03:04:02

Label at a glance#

ProductMUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT
Active ingredientHEXYLRESORCINOL
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: 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

Storage and handling

store at 20-25°C (68-77°F) protect contents from humidity Keep lozenge in outer pack until use. Reseal outer pack after use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Hexylresorcinol 2.4 mg

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 SECTION

Warnings

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • in children under 6 years of age

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor or dentist if

OTC - STOP USE SECTION

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • protect contents from humidity
  • Keep lozenge in outer pack until use. Reseal outer pack after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, D&C yellow no. 10, FD&C yellow no. 6, flavor, honey, propylene glycol, purified water, sucrose

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Nutley, NJ 07110-6100
Made in India

PRINCIPAL DISPLAY PANEL - 2.4 mg Pouch Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72854-261-20

Honey and Echinacea Front LabelHoney and Echinacea Front Label

Honey and Echinacea Back LabelHoney and Echinacea Back Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824215709GTIN-13: 0363824215709
EAN-13: 0363824215709
GTIN-12: 363824215709
UPC-A: 363824215709
GTIN storage (14 digits): 00363824215709
Honey and Echinacea Back Label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-261-20EA - Each72854-261088a8fa7-d2ce-4ff3-a40b-39039f28693712021-09-07
72854-261-40EA - Each72854-26172fcdb4f-c4ab-4b76-a237-3670d666d39b12021-09-07

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-26172854-261-20, 72854-261-40, 72854-261-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-13full-release2026-06-01 01:57:22

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
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
ndc (package): 72854-261-20
ndc (package): 72854-261-14
ndc (package): 72854-261-40
ndc (product): 72854-261
ndc11 (package): 72854026140
ndc11 (package): 72854026114
ndc11 (package): 72854026120
spl id: 5a5de58d-7914-1b01-e063-6394a90a4f95
spl set id: 91cd2964-5d83-4e40-bc18-e3e5462f454a

Reported adverse events (FAERS/openFDA)#

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