Refenesen Mucus Relief

Manufacturer
Reese Pharmaceutical Co
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:44:40

Label at a glance#

ProductRefenesen Mucus Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin
Label structure12 sections

Indications and uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.

Dosage and administration

■ Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed. ■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. ■ Children under 6 years of age: consult a doctor.    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Storage and handling

Store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active ingredients - (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Hydrobromide   20mg
Guaifenesin  400mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.

Warnings

WARNINGS SECTION

Do not use  ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)

Stop use and ask doctor if

OTC - STOP USE SECTION

■ symptoms are accompanied by fever, rash or persistent headache

■ cough persists for more than 1 week or tends to recur.

A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In  case of overdose, get medical help or contact a Poison Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.   
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin, Stearic acid, Povidone K30, Povidone 90F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of displayimage of display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN5
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD5
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-846-30Refenesen Mucus ReliefDM30 in 1 BOTTLETABLET305
10956-846-30Refenesen Mucus ReliefDM1 in 1 CARTONTABLET15
10956-846-50Refenesen Mucus ReliefDM50 in 1 BOTTLETABLET505
10956-846-50Refenesen Mucus ReliefDM1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-846REFENESEN MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]5Current NDC, Legacy NDC, 4 package rows20241220_6046dc50-f162-4e2d-aa3c-7d27efad477d.zip

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
10956-84610956-846-30, 10956-846-50

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

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
Refenesen Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINReese Pharmaceutical Co6046dc50-f162-4e2d-aa3c-7d27efad477d2024-12-18WarningsExact identifier
ndc (package): 10956-846-50
ndc (package): 10956-846-30
ndc (product): 10956-846
ndc11 (package): 10956084650
ndc11 (package): 10956084630
spl id: 05d6a014-cf43-4f17-afd9-014267e1d9ff
spl set id: 6046dc50-f162-4e2d-aa3c-7d27efad477d

Reported adverse events (FAERS/openFDA)#

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