Qch Maximum Strength Mucus Relief Dm 628

Qch Maximum Strength Mucus Relief Dm 628
SPL v1
SPL
SPL Set ID a2795bf5-34c6-4de6-b9e5-53a23d18e357
Route
ORAL
Published
Effective Date 2024-04-26
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 D&c Red No. 33 Dextrose, Unspecified Form Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Saccharin Sodium Sodium Hydroxide Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-26

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

Use(s)
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep


Warnings

.

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults & children 12 years & older: 20 mL every 4 hours
  • Children under 12 years of age: Do not use












Do Not Use
  • for children under 12 years of age
  • 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: potassium 20 mg, sodium 20 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40,  flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum.

When Using This Product
  • do not use more than directed
Ask A Doctor Before Use If
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Stop Use and Ask 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 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



Package Label.principal Display Panel

NDC 83324-026-06

QUALITY CHOICE®

*Compare to the Active Ingredient Maximum  Strength Mucinex Fast Max DM®  

 

Maximum Strength

Mucus

Relief



Cough Suppressant / Expectorant

Dextromethorphan HBr, 20 mg Per 20 mL

Guaifenesin, 400 mg Per 20 mL


Helps Control Cough 

Relieves Chest Congestion 

Thins and Loosens Mucus

Cherry Flavor

6 FL OZ (177 mL)









 




Structured Label Content

Use(s) (USE(S))
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep


Purpose (PURPOSE)

Cough Suppressant

Expectorant



Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults & children 12 years & older: 20 mL every 4 hours
  • Children under 12 years of age: Do not use












Do Not Use (DO NOT USE)
  • for children under 12 years of age
  • 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: potassium 20 mg, sodium 20 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40,  flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum.

When Using This Product (WHEN USING THIS PRODUCT)
  • do not use more than directed
Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Stop Use and Ask Doctor If (STOP USE AND ASK 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 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



Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 83324-026-06

QUALITY CHOICE®

*Compare to the Active Ingredient Maximum  Strength Mucinex Fast Max DM®  

 

Maximum Strength

Mucus

Relief



Cough Suppressant / Expectorant

Dextromethorphan HBr, 20 mg Per 20 mL

Guaifenesin, 400 mg Per 20 mL


Helps Control Cough 

Relieves Chest Congestion 

Thins and Loosens Mucus

Cherry Flavor

6 FL OZ (177 mL)









 




Advanced Ingredient Data


Raw Label Data

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