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Mucinex Fast-Max Cold, Flu and Sore Throat

Dosage form: solution
Ingredients: acetaminophen 650mg in 20mL, dextromethorphan hydrobromide 20mg in 20mL, guaifenesin 400mg in 20mL, phenylephrine hydrochloride 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-015

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®
Cold, Flu & Sore Throat

Drug Facts

Active ingredients
(in each 20 mL)
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • stuffy nose
    • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


Liver warning

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

Allergy alert

Acetaminophen may cause sever skin reactions. Symptoms may include:

  • skin reddening
  • blister
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

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.
  • 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
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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)

Ask a doctor or pharmacist before use if you are taking the blood thining drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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



You may also report side effects to this phone number.

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


NDC 63824-015-66



Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

Controls Cough, Thins & Loosens Mucus
Nasal & Chest Congestion
Sinus Pressure & Congestion
Body Pain, Headache, Fever & Sore Throat

6 FL OZ (180 mL)


acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen650 mg  in 20 mL
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 
propylene glycol 
propyl gallate 
sodium benzoate 
trisodium citrate dihydrate 
xanthan gum 
Product Characteristics
FlavorFRUITImprint Code
#Item CodePackage Description
1NDC:63824-015-66180 mL in 1 BOTTLE
2NDC:63824-015-69266 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: 09/2017
Reckitt Benckiser LLC

← See all Mucinex Fast-Max Cold, Flu and Sore Throat 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.