FDA.reportPublic FDA data

Mucus Relief D Sinus Congestion

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC | LNK International, Inc.
Effective date
2024-03-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:08:43

Label at a glance#

ProductMucus Relief D Sinus Congestion
Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive promotes nasal and/or sinus drainage temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and administration

adults and children 12 years and over: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours. children under 12 years: do not use

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg
Pseudoephedrine HCl 40 mg

Purpose

OTC - PURPOSE SECTION

Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • promotes nasal and/or sinus drainage
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 you have

OTC - ASK DOCTOR SECTION

  • cough accompanied by too much phlegm (mucus)
  • heart disease
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs or 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 Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC®
QUALITY
CHOICE

NDC 63868-801-27

Mucus Relief D
Sinus Congestion
Guaifenesin 400 mg
Pseudoephedrine HCl 40 mg

Expectorant
Nasal Decongestant

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus

Immediate Release

Actual Size

27 Tablets

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

50844       ORG041954772

SATISFACTION
100 %
QC
GUARANTEED

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Quality Choice 44-547Quality Choice 44-547

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-801-27EA - Each63868-8014971bb29-f785-414b-847a-7709f175a46812022-09-12

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-80163868-801-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
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
8f696bfa-ffe9-4b55-a680-92b87e686059a5021139-9001-40d5-830e-d8b1ccd00d132025-03-12WarningsExact identifier
spl set id: a5021139-9001-40d5-830e-d8b1ccd00d13

Reported adverse events (FAERS/openFDA)#

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