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Mucinex Fast-Max Congestion and Headache Clear and Cool

Medically reviewed on May 2, 2018

Dosage form: solution
Ingredients: ACETAMINOPHEN 650mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-545

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®
Congestion and Headache Clear & Cool

Drug Facts

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

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • minor aches and pains
    • 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

Warnings

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 severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

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 thinning 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 rash or headache that lasts. These cough 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.

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
  • 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)
  • dosing cup provided
  • do not refrigerate

Inactive ingredients

anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

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

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

NDC 63824-545-66

MAXIMUM STRENGTH*

Mucinex®
FAST-MAX®

CONGESTION &
HEADACHE

CLEAR & COOL

Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

Relieves Headache & Fever
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

6 FL OZ (180mL)
FOR AGES 12+

MUCINEX FAST-MAX   CONGESTION AND HEADACHE CLEAR AND COOL
acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-545
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 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 
D&C yellow no. 10 
edetate disodium 
FD&C blue no. 1 
glycerin 
propyl gallate 
propylene glycol 
sodium benzoate 
sodium citrate, unspecified form 
sorbitol 
sucralose 
water 
xanthan gum 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-545-66180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2016
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

Further information

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

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