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← See all Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength brands

Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength

Dosage form: kit
Ingredients: Dextromethorphan Hydrobromide 20mg in 20mL, Guaifenesin 400mg in 20mL, Phenylephrine Hydrochloride 10mg in 20mL; Acetaminophen 650mg in 20mL, Diphenhydramine Hydrochloride 25mg in 20mL, Phenylephrine Hydrochloride 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-528

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® Day Time Severe Congestion and Cough and Mucinex® Fast-Max® Night Time Cold and Flu
Maximum Strength

Drug Facts

Active ingredients (in each 20 mL)
Mucinex FAST-MAX Day Time Severe Congestion & Cough
Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant
Active ingredients (in each 20 mL)Purposes
Mucinex FAST-MAX Night Time Cold & Flu
Acetaminophen 650 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine/cough suppressant
Phenylephrine HCl 10 mgNasal decongestant

Uses
  • temporarily relieves (Day Time only):
    • 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Day Time only)
  • temporarily relieves these common cold and flu symptoms (Night Time only)
    • nasal congestion
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • runny nose and sneezing
  • temporarily reduces fever (Night Time only)
  • controls cough to help you get to sleep

Warnings

Liver warning (Night Time only)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning (Night Time only): if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Night Time only)
  • with any other drug containing diphenhydramine, even one used on the skin (Night Time only)
  • 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.
  • for children under 12 years of age

Ask a doctor before use if you have
  • liver disease (Night Time only)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Night Time only)
  • a breathing problem such as emphysema or chronic bronchitis (Night Time only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin (Night Time only)
  • taking sedatives or tranquilizers (Night Time only)

When using this product do not use more than directed.

In addition, for Night Time only:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever (Day Time only)
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days (Night Time only)
  • fever gets worse, or lasts more than 3 days (Night Time only)
  • redness or swelling is present (Night Time only)
  • new symptoms occur (Night Time only)
  • 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 right away.

Overdose warning (Night Time only)

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see Overdose warning)
  • 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 (DAY TIME only) and sodium 12 mg (NIGHT TIME only)
  • do not refrigerate
  • store between 20-25°C (68-77°F)
  • dosing cup provided

Inactive ingredients (Day Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum


may contain this ingredient

Inactive ingredients (Night Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #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)

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

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-528-22

MAXIMUM STRENGTH*

Mucinex®
FAST-MAX®

DAY TIME
Severe Congestion
& Cough

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

Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

Mucinex®
FAST-MAX®

NIGHT TIME
Cold & Flu

Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine/Cough Suppressant
Phenylephrine HCl • Nasal Decongestant

Relieves Aches,
Fever & Sore Throat
Controls Cough
Relieves Nasal Congestion
Relieves Runny Nose & Sneezing

*per 4 hour dose.

AGE 12+ TWO – 6 fl oz (180 mL) bottles TOTAL – 12 fl oz (360 mL) AGE 12+

MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-528
Packaging
#Item CodePackage Description
1NDC:63824-528-221 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 180 mL
Part 21 BOTTLE 180 mL
Part 1 of 2
MUCINEX FAST-MAX   SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Item 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
FlavorFRUIT Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-014-66180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/07/2012
Part 2 of 2
MUCINEX FAST-MAX   NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:63824-500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg  in 20 mL
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 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
FlavorFRUIT Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-500-66180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/09/2014
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

← See all Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength brands

Medically reviewed on May 14, 2018

Further information

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

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