FDA.reportPublic FDA data

MUCINEX® INSTASOOTHE®

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-03 03:02:41

Label at a glance#

ProductMUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF
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

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...

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 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

  • dose as follows or as directed by a doctor or dentist
adults and children 12 years of age and oldertake 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 agetake 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 2 hours as needed
children under 6 years of agedo 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, FD&C blue no. 1, FD&C red no. 40, flavor, 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 - 20 Drop Pouch Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72854-262-20

Elderberry and Wild Cherry Front LabelElderberry and Wild Cherry Front Label

Elderberry and Wild Cherry Back LabelElderberry and Wild Cherry Back Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-262-20EA - Each72854-2624a583349-9284-4b95-bb31-6be5a4e5af0f12022-05-04
72854-262-40EA - Each72854-262afeb9329-5399-4549-ae22-6e0f9eb4a8b112022-05-04

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-26272854-262-20, 72854-262-40, 72854-262-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXYLRESORCINOLR9QTB5E82NACTIB
CORN SYRUP9G5L16BK6NIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-07-03weekly-update2026-07-17 21:43:33
62026-05-13full-release2026-06-01 01:57:18
52025-11-05monthly-update2026-06-03 17:38:48
42025-09-12full-release2026-06-01 01:13:36

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 PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
ndc (package): 72854-262-16
ndc (package): 72854-262-40
ndc (package): 72854-262-20
ndc (product): 72854-262
ndc11 (package): 72854026240
ndc11 (package): 72854026216
ndc11 (package): 72854026220
spl id: 5a5e71da-010b-1728-e063-6294a90aeb2b
spl set id: 4c150222-06ea-4fcf-967f-84e19846bd66

Reported adverse events (FAERS/openFDA)#

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