MUCINEX® InstaSoothe®

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-08-03
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: daily-update
Hydrated at: 2026-08-06 06:10:22

Label at a glance#

ProductMUCINEX INSTASOOTHE COUGH

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE

Label structure11 sections

Indications and uses

temporarily: ■ relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ helps reduce the intensity of coughing

Contacts and useful links#

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

(in each Lozenge)

Purpose

Dextromethorphan HBr 5 mg

Cough suppressant

OTC - PURPOSE SECTION

Dextromethorphan HBr 5 mg: Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily:
■ relieves cough due to minor throat and bronchial irritation as may occur with the common
cold or inhaled irritants
■ helps reduce the intensity of coughing

Warnings

WARNINGS SECTION

Do Not Use
■ 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.

Ask a doctor before use if you have
■ 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 if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breastfeeding, 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

Label

Other Infomation

OTHER SAFETY INFORMATION

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

FD&C blue no. 1, FD&C red no. 40, flavor, hydrogenated starch
hydrolysate, isomalt, propylene glycol, 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72854-267 front label

72854-267 back label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	50077436		72854-267 back label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72854-267-20	EA - Each	72854-267	836920bc-7166-46f3-a57b-8497b882522e	1	2024-08-12
72854-267-40	EA - Each	72854-267	15509d01-1596-4932-b9fd-f2627ee5a844	1	2024-08-12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

MUCINEX INSTASOOTHE COUGH
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
FD&C RED NO. 40
ISOMALT
PROPYLENE GLYCOL
FD&C BLUE NO. 1
WATER
SUCRALOSE
HYDROGENATED STARCH HYDROLYSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72854-267	72854-267-20, 72854-267-40

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
FD&C RED NO. 40	WZB9127XOA	IACT
ISOMALT	S870P55O2W	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
HYDROGENATED STARCH HYDROLYSATE	27F77DSJ5V	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
4	2026-05-13	full-release	2026-06-01 01:57:16

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCINEX INSTASOOTHE COUGH	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	0d99237c-0b52-0af6-e063-6394a90aba14	2026-08-03	Warnings	Exact identifier ndc (package): 72854-267-20 ndc (package): 72854-267-40 ndc (product): 72854-267 ndc11 (package): 72854026720 ndc11 (package): 72854026740 spl id: 582c85e6-2982-ef3b-e063-6394a90a383a spl set id: 0d99237c-0b52-0af6-e063-6394a90aba14

Reported adverse events (FAERS/openFDA)#

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