FDA.reportPublic FDA data

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 03:04:00

Label at a glance#

ProductMUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, HEXYLRESORCINOL
Label structure10 sections

Indications and uses

temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold occasional irritation and pain due to a sore mouth or sore throat pain associated with 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 4 hours as needed, not to exceed 12 lozenges in any 24-hour period children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated ever...

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each lozenge)
Dextromethorphan HBr 5 mg
Hexylresorcinol 2 mg

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Hexylresorcinol 2 mgOral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • cough due to minor throat and bronchial irritation as may occur with the common cold
  • occasional irritation and pain due to a sore mouth or sore throat
  • pain associated with 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

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • in children under 6 years of age

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

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 develops
  • 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

  • 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 4 hours as needed, not to exceed 12 lozenges in any 24-hour period
children 6 to under 12 years of agetake 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in any 24-hour period
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, D&C yellow no. 10, ethyl lactate, FD&C blue no. 1, 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 Thailand

PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72854-263-20

Fresh Mint Front LabelFresh Mint Front Label

Fresh Mint Back LabelFresh Mint Back Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-263-20EA - Each72854-26398c1a2e9-942a-4b77-8d28-835d7553323012021-09-07
72854-263-40EA - Each72854-2639e51bfe4-8dba-4f7e-9c61-a652824542ca12021-09-07

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-26372854-263-20, 72854-263-40

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
HEXYLRESORCINOLR9QTB5E82NACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
ETHYL LACTATEF3P750VW8IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-27full-release2026-06-01 01:59:11
42026-05-13weekly-update2026-06-03 18:02:47

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 RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
ndc (package): 72854-263-20
ndc (package): 72854-263-40
ndc (product): 72854-263
ndc11 (package): 72854026340
ndc11 (package): 72854026320
spl id: 5a5f2710-9a16-e17c-e063-6294a90af062
spl set id: 8d670d91-9e22-45b9-b568-5b62c2133d32

Reported adverse events (FAERS/openFDA)#

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