MUCINEX® INSTASOOTHE® SORE THROAT PLUS COUGH

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-09-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-03 03:01:59

Label at a glance#

ProductMUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE
Active ingredientHEXYLRESORCINOL, MENTHOL
Label structure11 sections

Indications and 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

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 ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Hexylresorcinol 2 mg

Menthol 6.1 mg

Purpose

OTC - PURPOSE SECTION

Hexylresorcinol 2 mg - Oral pain reliever
Menthol 6.1 mg - Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

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

OTC - STOP USE SECTION

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.

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

D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavor, hydrogenated
starch hydrolysate, isomalt, purified water, sucralose

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72854-268 front label72854-268 front label

72854-268 back label72854-268 back label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5007743072854-268 back label.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-26872854-268-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-08-03daily-update2026-08-06 06:10:27
22026-06-02daily-update2026-06-04 05:10:06
12026-02-11daily-update2026-06-03 18:04:06

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 COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
ndc (package): 72854-268-32
ndc (product): 72854-268
ndc11 (package): 72854026832
spl id: 5a6f82bb-8b33-af4f-e063-6394a90a7ed8
spl set id: 4a938e15-a996-8538-e063-6294a90ad4ee

Reported adverse events (FAERS/openFDA)#

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