FDA.reportPublic FDA data

Mucus Relief DM

Manufacturer
Allegiant Health
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:12

Label at a glance#

ProductMucus Relief DM Immediate Release
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Dosage and administration

Adults and children 12 years and older : take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age:  do not use

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20mg
Guaifenesin 400mg 

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Use(s)

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as
    occurs with smoking, asthma, chronic
    bronchitis or emphysema
  • cough accompanied by too much phlegm (mucus

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-888-952-0050
Monday through Friday 9AM- 5PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucus Relief DMMucus Relief DM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN3
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD3
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY3

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
69168-432-06Mucus Relief DMImmediate Release120 in 1 BOTTLETABLET1203
69168-432-07Mucus Relief DMImmediate Release10 in 1 BOTTLETABLET103
69168-432-07Mucus Relief DMImmediate Release1 in 1 CARTONTABLET13
69168-432-26Mucus Relief DMImmediate Release1 in 1 CARTONTABLET13
69168-432-26Mucus Relief DMImmediate Release20 in 1 BOTTLETABLET203
69168-432-30Mucus Relief DMImmediate Release30 in 1 BOTTLETABLET303
69168-432-50Mucus Relief DMImmediate Release50 in 1 BOTTLETABLET503
69168-432-98Mucus Relief DMImmediate Release200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-432MUCUS RELIEF DM IMMEDIATE RELEASE (MUCUS RELIEF DM) TABLET [ALLEGIANT HEALTH]3Current NDC, Legacy NDC, 8 package rows20231107_731f8608-ad5b-491e-a4d4-2bb0c423fed5.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
69168-43269168-432-98, 69168-432-07, 69168-432-26, 69168-432-50, 69168-432-06, 69168-432-30

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
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT

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
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
ndc (package): 69168-432-26
ndc (package): 69168-432-30
ndc (package): 69168-432-98
ndc (package): 69168-432-06
ndc (package): 69168-432-50
ndc (package): 69168-432-07
ndc (product): 69168-432
ndc11 (package): 69168043206
ndc11 (package): 69168043226
ndc11 (package): 69168043250
ndc11 (package): 69168043230
ndc11 (package): 69168043298
ndc11 (package): 69168043207
spl id: 751cf188-7b5f-4f9d-ba3e-8ce7997ecd31
spl set id: 731f8608-ad5b-491e-a4d4-2bb0c423fed5

Reported adverse events (FAERS/openFDA)#

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