FDA.reportPublic FDA data

Medique Medi-Mucus

Manufacturer
Unifirst First Aid Corporation | Prestige Packaging | Medique Products
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:13:07

Label at a glance#

ProductMedique Medi-Mucus
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • 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 irritations as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get sleep

WARNINGS SECTION

Warnings

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed

OTC - STOP USE SECTION

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 illness.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children (12 years of age 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 SAFETY INFORMATION

Other information

  • store between 68-77ºF (20-25ºC)
  • keep in a dry place and do not expose to heat
  • tamper-evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique®

Medi-Mucus

Cough Suppressant • Dextromethorphan HBr 20 mg

Expectorant • Guaifenesin 400 mg

Controls Coughs Thins & Loosens Mucus

Pull to Open

Tamper Evident Unit Dose Packets

Collect MediBuckSee inside flap for more details

50 Tablets (50 x 1)

Medique MediMucusMedique MediMucus

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-432-46Medique Medi-Mucus1 in 1 PACKETTABLET13
47682-432-50Medique Medi-Mucus50 in 1 BOXTABLET503

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
47682-43247682-432-46, 47682-432-50

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
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
POVIDONEFZ989GH94EIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
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
Medique Medi-MucusDEXTROMETHORPHAN HBR, GUAIFENESINUnifirst First Aid Corporationf3bb862a-9cb8-f644-e053-2a95a90a5f4f2025-09-08WarningsExact identifier
ndc (package): 47682-432-46
ndc (package): 47682-432-50
ndc (product): 47682-432
ndc11 (package): 47682043250
ndc11 (package): 47682043246
spl id: 3e4c4508-dcb7-1c71-e063-6394a90a328b
spl set id: f3bb862a-9cb8-f644-e053-2a95a90a5f4f

Reported adverse events (FAERS/openFDA)#

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