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Mucinex Fast-Max Severe Congestion and Cough

Medically reviewed on October 2, 2017

Dosage form: solution
Ingredients: dextromethorphan hydrobromide 20mg in 20mL, guaifenesin 400mg in 20mL, phenylephrine hydrochloride 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-540

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mucinex® Fast-Max®
Severe Congestion & Cough

Drug Facts

Active ingredients (in each 20 mL)Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

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

WARNINGS

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.

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)

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 lasts more than 7 days, 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 right away.

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 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 9 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum


may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

MAXIMUM STRENGTH
NDC 63824-540-66

Mucinex®
FAST-
MAX®

SEVERE CONGESTION
& COUGH

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

6 FL OZ (180 mL)
FOR AGES 12+

031717
3046243

MUCINEX FAST-MAX   SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-540
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide20 mg  in 20 mL
guaifenesin (guaifenesin) guaifenesin400 mg  in 20 mL
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
PROPYL GALLATE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
TRISODIUM CITRATE DIHYDRATE 
XANTHAN GUM 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-540-66180 mL in 1 BOTTLE
2NDC:63824-540-69266 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/2017
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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