Qch Maximum Strength Mucus Relief  617

Qch Maximum Strength Mucus Relief  617
SPL v1
SPL
SPL Set ID a1c5c15e-0f3a-47d3-b9ed-1e0018417514
Route
ORAL
Published
Effective Date 2024-09-06
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 Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-06

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg 

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 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 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

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 and children 12 years and older: 20 ml in dosing cup provided 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: sodium 20 mg

• store between 15-30ºC (59-86ºF)

• do not refrigerate

• dosing cup provided

Inactive Ingredients

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum. 

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

NDC 83324-144-06

QC® QUALITY CHOICE

*Compare to the Active Ingredients in Maximum Strength Mucinex® Fax MaxTM  Severe Congestion & Cough

Maximum Strength Mucus Relief Sever Congestion & Cough

Dextromethorphan HBr 20 mg - Cough suppressant

Guaifenesin 400 mg -
Expectorant

Phenylephrine HCI 10 mg -
Nasal decongestant

Helps Control Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

6 FL OZ (177 mL)

When Using This Product

• do not use more than directed

Stop Use and Ask Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
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 HCI 10 mg 

Ask A Doctor Before Use If You Have

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

• cough that occurs with too much phlegm (mucus)


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 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 (PURPOSE)

Cough suppressant

Expectorant

Nasal decongestant

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 and children 12 years and older: 20 ml in dosing cup provided 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: sodium 20 mg

• store between 15-30ºC (59-86ºF)

• do not refrigerate

• dosing cup provided

Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum. 

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-144-06

QC® QUALITY CHOICE

*Compare to the Active Ingredients in Maximum Strength Mucinex® Fax MaxTM  Severe Congestion & Cough

Maximum Strength Mucus Relief Sever Congestion & Cough

Dextromethorphan HBr 20 mg - Cough suppressant

Guaifenesin 400 mg -
Expectorant

Phenylephrine HCI 10 mg -
Nasal decongestant

Helps Control Cough

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

6 FL OZ (177 mL)

When Using This Product (WHEN USING THIS PRODUCT)

• do not use more than directed

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
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 HCI 10 mg 

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

• cough that occurs with too much phlegm (mucus)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)