Mucus Relief DM

Manufacturer
Healthlife of USA LLC | Elysium Pharmaceuticals Limited
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:23:41

Label at a glance#

ProductMucus Relief DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure16 sections

Indications and uses

Helps loosen phlegm (mucus) Helps thin bronchial secretions to make coughs more productive Temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold 

Dosage and administration

Adults and children 12 years of age and over:  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:  Do not use

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Immediate Release Mucus Relief DM 

Active Ingredients 

OTC - ACTIVE INGREDIENT SECTION

  • Guaifenesin 400mg
  • Dextromethorphan HBr 15mg 

Purpose 

OTC - PURPOSE SECTION

Expectorant, Cough Suppressant 

Uses

INDICATIONS & USAGE SECTION

  • Helps loosen phlegm (mucus)
  • Helps thin bronchial secretions to make coughs more productive
  • Temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold 

Warnings

WARNINGS SECTION

Do not use: 

  • If you are now taking a prescriprion 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 

OTC - ASK DOCTOR SECTION

  • Persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • Cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Taking sedatives or Tranquilizers

When using this product

OTC - WHEN USING SECTION

  • Do not exceed recommended dosage
  • Do ot use for more than 7 days

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistant headache. These could be signs 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 overdosage, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: 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: Do not use

Other Information

OTC - QUESTIONS SECTION

  • Each Tablet contains: sodium 1.24 mg VERY LOW SODIUM
  • 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
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Colloidal silicon dioxide
  • Magnesium stearate
  • Microcrystalline Cellulose
  • Sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Immediate Release Mucus Relief DM Guaifenesin 400mg / Expectorant Dextromethorphan HBr 15 mg/ Cough Suppressant  Controls Cough Thins and Loosens Mucus 12 Tablets  Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-120MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR TABLETS) TABLET [HEALTHLIFE OF USA LLC]6Legacy NDC20231021_53d4d306-3175-49e3-8c30-eae71a332f09.zip

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-12069517-120-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
404e4bfa-2ef7-3b90-e063-6394a90a578253d4d306-3175-49e3-8c30-eae71a332f092025-10-04WarningsExact identifier
spl set id: 53d4d306-3175-49e3-8c30-eae71a332f09

Reported adverse events (FAERS/openFDA)#

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