drug facts

drug facts
SPL v5
SPL
SPL Set ID d344f239-692e-45a0-9ee9-f88ca652e553
Route
oral
Published
Effective Date 2024-05-01
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 propyl gallate propylene glycol water sodium benzoate trisodium citrate dihydrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-01-31
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 6 doses in a 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
  • mL=milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use


Other Information
  • each 20 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydate, xanthan gum

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Principal Display Panel

*Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

Multi-Symptom Relief

Mucus Relief

Severe Congestion & Cough

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Chest Congestion & Mucus

Phenylephrine HCl

Stuffy Nose

For Ages 12+

Distributed by CDMA Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough.

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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.
Package Label
Quality Choice Multi-Symptom Relief Mucus Relief
When Using This Product,

do not use more than directed

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 comes back, or occurs with fever rash or headache that lasts. 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 (1-800-222-1222) 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
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • 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

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
Directions
  • do not take more than 6 doses in a 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
  • mL=milliliter
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use


Other Information (Other information)
  • each 20 mL contains: sodium 14 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydate, xanthan gum

Principal Display Panel

*Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

Multi-Symptom Relief

Mucus Relief

Severe Congestion & Cough

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Chest Congestion & Mucus

Phenylephrine HCl

Stuffy Nose

For Ages 12+

Distributed by CDMA Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough.

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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.
Package Label
Quality Choice Multi-Symptom Relief Mucus Relief
When Using This Product, (When using this product,)

do not use more than directed

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 comes back, or occurs with fever rash or headache that lasts. 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 (1-800-222-1222) 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)
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.563629 · Updated: 2026-03-14T23:02:53.135799