MedPath

Mucus Relief Severe Congestion and Cough

Quality Choice 44-004

Approved
Approval ID

2a7afe03-3c34-4e30-827e-b3bb2568cb97

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Chain Drug Marketing Association, Inc.

DUNS: 011920774

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83324-077
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (15)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 20 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 20 mL
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 20 mL
Code: 04JA59TNSJ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Principal Display Panel

QC®
** QUALITY**
** CHOICE**

NDC 83324-077-06

Compare to the Active
Ingredients in Maximum Strength
Mucinex® FAST-MAX® Severe
Congestion & Cough*

Maximum Strength
** Mucus**
** Relief**
** Severe Congestion & Cough**
** Dextromethorphan HBr** - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

Controls Cough
Relieves Nasal &
Chest Congestion
Thins & Loosens Mucus

For ages 12 years & over

Mixed Berry
** Flavored**

6 FL OZ (177 mL)

Distributed by CDMA, Inc.
** Novi, MI 48375**
** www.qualitychoice.com**
** Questions: 800-935-2362**

SATISFACTION
** GUARANTEED**
****100%
****QC

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
** SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

*This product is not manufactured or distributed
by RB Health (US) LLC, owner of the registered
trademark Maximum Strength Mucinex®
FAST-MAX® Severe Congestion & Cough.
50844 ORG072400445

![Quality Choice 44-004](/dailymed/image.cfm?name=quality- choice-44-004-1.jpg&id=897910)

Quality Choice 44-004

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

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 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
    • nasal congestion due to a cold

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/16/2025

Other information

*each 20 mL contains: sodium 9 mg

  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/16/2025

Questions or comments?

1-800-426-9391

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Directions

*do not take more than directed

  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

Cough suppressant
Expectorant
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

Warnings

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.

Ask a doctor before use if you have

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

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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Mucus Relief Severe Congestion and Cough - FDA Drug Approval Details