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Mucinex Fast-Max Severe Congestion and Cough

Dosage form: solution
Ingredients: dextromethorphan hydrobromide 20mg in 20mL, guaifenesin 400mg in 20mL, phenylephrine hydrochloride 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-014

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.

MAXIMUM STRENGTH
Mucinex®
FAST-MAX™
Severe Congestion
& Cough

Drug Facts

Active ingredients
(in each 20 mL)
Purpose
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
  • 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.

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 comes back, or occurs with 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.

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
  • mL = milliliter
  • 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.

Other information
  • each 20 mL contains: sodium 14 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, 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

Made in England

Made in India

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

032312
8016190

MAXIMUM STRENGTH
NDC 63824-014-66

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+

MUCINEX FAST-MAX   SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-014
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 Blue NO. 1 
FD&C Red NO. 40 
glycerin 
propyl gallate 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
trisodium citrate dihydrate 
xanthan gum 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-014-66180 mL in 1 BOTTLE
2NDC:63824-014-69266 mL in 1 BOTTLE
3NDC:63824-014-222 BOTTLE in 1 CELLO PACK
3NDC:63824-014-69266 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/07/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 10/2013
 
Reckitt Benckiser LLC

← See all Mucinex Fast-Max Severe Congestion and Cough brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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