quality choice 44-004

quality choice 44-004
SPL v2
SPL
SPL Set ID 2a7afe03-3c34-4e30-827e-b3bb2568cb97
Route
oral
Published
Effective Date 2025-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg) phenylephrine (10 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate trisodium citrate dihydrate sodium metabisulfite sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2025-09-15

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg


Medication Information

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
Purpose

Cough suppressant

Expectorant

Nasal decongestant

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
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 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

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

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
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.

Questions Or Comments?

1-800-426-9391

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.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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)

Structured Label Content

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
Purpose

Cough suppressant

Expectorant

Nasal decongestant

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
Other Information (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 Ingredients (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

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
Do Not Use (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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data


Raw Label Data

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