Quality Choice 44-030

Quality Choice 44-030
SPL v2
SPL
SPL Set ID b0d38db9-22a9-4dd8-8e0f-dd81805e724b
Route
ORAL
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-04

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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
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. 

Other Information
  • each 20 mL contains: sodium 16 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC

Quality

Choice 
®

NDC 83324-324-04

Compare to the

Active Ingredients in

Robitussin® Maximum

Strength Cough+Chest

Congestion DM*

Tussin DM

Maximum Strength

Dextromethorphan HBr

Guaifenesin

Cough Suppressant

Expectorant

Oral Solution

Controls Cough

Relieves Chest Congestion

Thins & Loosens Mucus

For Ages 12 Years & Over

Menthol-Berry Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Haleon US Holdings LLC, owner of the registered

trademark Robitussin® MAXIMUM STRENGTH

Cough+Chest Congestion DM.

50844 ORG032503036

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-030
Stop Use and Ask A Doctor If

cough persists more than 7 days, 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

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Purpose

Cough suppressant

Expectorant

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
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. 

Other Information (Other information)
  • each 20 mL contains: sodium 16 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC

Quality

Choice 
®

NDC 83324-324-04

Compare to the

Active Ingredients in

Robitussin® Maximum

Strength Cough+Chest

Congestion DM*

Tussin DM

Maximum Strength

Dextromethorphan HBr

Guaifenesin

Cough Suppressant

Expectorant

Oral Solution

Controls Cough

Relieves Chest Congestion

Thins & Loosens Mucus

For Ages 12 Years & Over

Menthol-Berry Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Haleon US Holdings LLC, owner of the registered

trademark Robitussin® MAXIMUM STRENGTH

Cough+Chest Congestion DM.

50844 ORG032503036

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-030
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough persists more than 7 days, 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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data


Raw Label Data

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