Mucinex® Fast-max ®

Mucinex® Fast-max ®
SPL v5
SPL
SPL Set ID 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc
Route
ORAL
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Triprolidine (2.5 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Anhydrous Citric Acid Ascorbic Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Propylene Glycol Sodium Benzoate Sorbitol Sucralose Triacetin Triethyl Citrate Water Xanthan Gum Propyl Gallate Trisodium Citrate Dihydrate

Identifiers & Packaging

Pill Appearance
Color: blue Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Mucinex Fast-Max Severe Congestion & Cough



■ 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 ■ nasal congestion due to a cold



■ temporarily helps you cough less





Mucinex Nighttime Cold & Flu



■ temporarily relieves these common cold and flu symptoms:



■ cough ■ nasal congestion



■minor aches and pains ■ sore throat



■headache ■ sinus congestion and pressure



■runny nose ■ sneezing



■ itching of the nose or throat



■ itchy, watery eyes due to hay fever



■ temporarily reduces fever



■ controls cough to help you get to sleep

Section 42229-5

Drug Facts

Section 43683-2

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool

■ 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 ■ nasal congestion due to a cold

■ temporarily helps you cough less



Mucinex Nightshift Cold & Flu Clear & Cool

■ temporarily relieves these common cold and flu symptoms:

■ cough ■ nasal congestion

■minor aches and pains ■ sore throat

■headache ■ sinus congestion and pressure

■runny nose ■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes due to hay fever

■ temporarily reduces fever

■ controls cough to help you get to sleep

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 20 mL)

Mucinex Fast-Max Severe Congestion & Cough
Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Active ingredients (in each 20 mL)

Mucinex Nightshift Cold & Flu
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Triprolidine HCl 2.5 mg Antihistamine
Section 55106-9

Dextromethorphan HBr 20 mg..............Cough suppressant

Guaifenesin 400 mg.................................Expectorant

Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Acetaminophen 650mg..........Pain reliever/fever reducer

Dextromethorphan HBr 20 mg..............Cough suppressant

Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant

Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine

Warnings

Liver warning (Nighttime Cold & Flu only): This product



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



■ more than 4000 mg 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 (Nighttime Cold & Flu only):



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.



Sore throat warning (Nighttime Cold & Flu 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.

Directions

Mucinex Fast-Max Severe Congestion & Cough



Clear & Cool



■ 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 over: 20 mL in dosing



cup provided every 4 hours



■ children under 12 years of age: do not use





Mucinex Nighttime Cold & Flu



■ do not take more than directed (see Overdose warning)



■ do not take more than 4 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 over: 20 mL in dosing cup



provided every 4 hours



■ children under 12 years of age: do not use

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. (Nightshift Cold & Flu 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.
Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Other Information

■ each 20 mL contains: sodium



9 mg (Fast-Max Severe



Congestion & Cough only) and sodium 16 mg



(Nighttime Cold & Flu l only)



■ store at 20-25°C (68-77°F)



■ do not refrigerate

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Cold & Flu only)
  • marked drowsiness may occur (Nightshift Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
  • fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
  • redness or swelling is present (Nightshift Cold & Flu only)
  • new symptoms occur (Nightshift Cold & Flu only)
  • cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
  • nervousness, dizziness, or sleeplessness occur (Fast-Max Severe Congestion & Cough only)
  • symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough only)
  • 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. (Fast-Max Severe Congestion & Cough only)
Mucinex Nightshift Cold & Flu
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Ask A Doctor Before Use If You Have
  • liver disease (Nightshift Cold & Flu only)
  • heart disease (Fast-Max Severe Congestion & Cough only)
  • high blood pressure (Fast-Max Severe Congestion & Cough only)
  • thyroid disease (Fast-Max Severe Congestion & Cough only)
  • diabetes (Fast-Max Severe Congestion & Cough only)
  • glaucoma (Nightshift Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton

DAY & NIGHT



COUGH & COLD RELIEF

MAXIMUM STRENGTH



NDC 72854-166-26

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

Mucinex®



NIGHTTIME

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Triprolidine HCl – Antihistamine

NIGHTTIME



RELIEF FOR A BETTER



MORNING

✓COUGH ✓FEVER ✓SORE THROAT



✓RUNNY NOSE ✓SNEEZING

FOR



AGES 12+

TWO – 6 FL OZ (180 mL) bottles



TOTAL – 12 FL OZ (360 mL)

FOR



AGES 12+

Allergy Alert (nightshift Cold & Flu Only)

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.

Liver Warning (nightshift Cold & Flu Only)

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

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Mucinex Fast Max Severe Congestion & Cough
  • 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
    • nasal congestion due to a cold
    • the impulse to cough to help you get to sleep
Overdose Warning (nightshift Cold & Flu 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.

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin (Nightshift Cold & Flu only)
  • taking sedatives or tranquilizers (Nightshift Cold & Flu only)
Sore Throat Warning (nightshift Cold & Flu 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.

Inactive Ingredients (mucinex Nighttime Cold & Flu)

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blueno.1, FD&Credno.40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Inactive Ingredients (mucinex Fast Max Severe Congestion & Cough)

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum *may contain this ingredient


Structured Label Content

Uses

Mucinex Fast-Max Severe Congestion & Cough



■ 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 ■ nasal congestion due to a cold



■ temporarily helps you cough less





Mucinex Nighttime Cold & Flu



■ temporarily relieves these common cold and flu symptoms:



■ cough ■ nasal congestion



■minor aches and pains ■ sore throat



■headache ■ sinus congestion and pressure



■runny nose ■ sneezing



■ itching of the nose or throat



■ itchy, watery eyes due to hay fever



■ temporarily reduces fever



■ controls cough to help you get to sleep

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool

■ 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 ■ nasal congestion due to a cold

■ temporarily helps you cough less



Mucinex Nightshift Cold & Flu Clear & Cool

■ temporarily relieves these common cold and flu symptoms:

■ cough ■ nasal congestion

■minor aches and pains ■ sore throat

■headache ■ sinus congestion and pressure

■runny nose ■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes due to hay fever

■ temporarily reduces fever

■ controls cough to help you get to sleep

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 20 mL)

Mucinex Fast-Max Severe Congestion & Cough
Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Active ingredients (in each 20 mL)

Mucinex Nightshift Cold & Flu
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Triprolidine HCl 2.5 mg Antihistamine
Section 55106-9 (55106-9)

Dextromethorphan HBr 20 mg..............Cough suppressant

Guaifenesin 400 mg.................................Expectorant

Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Acetaminophen 650mg..........Pain reliever/fever reducer

Dextromethorphan HBr 20 mg..............Cough suppressant

Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant

Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine

Warnings

Liver warning (Nighttime Cold & Flu only): This product



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



■ more than 4000 mg 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 (Nighttime Cold & Flu only):



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.



Sore throat warning (Nighttime Cold & Flu 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.

Directions

Mucinex Fast-Max Severe Congestion & Cough



Clear & Cool



■ 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 over: 20 mL in dosing



cup provided every 4 hours



■ children under 12 years of age: do not use





Mucinex Nighttime Cold & Flu



■ do not take more than directed (see Overdose warning)



■ do not take more than 4 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 over: 20 mL in dosing cup



provided every 4 hours



■ children under 12 years of age: do not use

Do Not Use (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. (Nightshift Cold & Flu 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.
Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Other Information (Other information)

■ each 20 mL contains: sodium



9 mg (Fast-Max Severe



Congestion & Cough only) and sodium 16 mg



(Nighttime Cold & Flu l only)



■ store at 20-25°C (68-77°F)



■ do not refrigerate

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Cold & Flu only)
  • marked drowsiness may occur (Nightshift Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
  • fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only)
  • redness or swelling is present (Nightshift Cold & Flu only)
  • new symptoms occur (Nightshift Cold & Flu only)
  • cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only)
  • nervousness, dizziness, or sleeplessness occur (Fast-Max Severe Congestion & Cough only)
  • symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough only)
  • 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. (Fast-Max Severe Congestion & Cough only)
Mucinex Nightshift Cold & Flu (MUCINEX NIGHTSHIFT COLD & FLU)
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease (Nightshift Cold & Flu only)
  • heart disease (Fast-Max Severe Congestion & Cough only)
  • high blood pressure (Fast-Max Severe Congestion & Cough only)
  • thyroid disease (Fast-Max Severe Congestion & Cough only)
  • diabetes (Fast-Max Severe Congestion & Cough only)
  • glaucoma (Nightshift Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

DAY & NIGHT



COUGH & COLD RELIEF

MAXIMUM STRENGTH



NDC 72854-166-26

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

Mucinex®



NIGHTTIME

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Triprolidine HCl – Antihistamine

NIGHTTIME



RELIEF FOR A BETTER



MORNING

✓COUGH ✓FEVER ✓SORE THROAT



✓RUNNY NOSE ✓SNEEZING

FOR



AGES 12+

TWO – 6 FL OZ (180 mL) bottles



TOTAL – 12 FL OZ (360 mL)

FOR



AGES 12+

Allergy Alert (nightshift Cold & Flu Only) (Allergy alert (Nightshift Cold & Flu only))

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.

Liver Warning (nightshift Cold & Flu Only) (Liver warning (Nightshift Cold & Flu only))

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

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Mucinex Fast Max Severe Congestion & Cough (MUCINEX FAST-MAX SEVERE CONGESTION & COUGH)
  • 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
    • nasal congestion due to a cold
    • the impulse to cough to help you get to sleep
Overdose Warning (nightshift Cold & Flu Only) (Overdose warning (Nightshift Cold & Flu 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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin (Nightshift Cold & Flu only)
  • taking sedatives or tranquilizers (Nightshift Cold & Flu only)
Sore Throat Warning (nightshift Cold & Flu Only) (Sore throat warning (Nightshift Cold & Flu 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.

Inactive Ingredients (mucinex Nighttime Cold & Flu) (Inactive ingredients (Mucinex Nighttime Cold & Flu))

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blueno.1, FD&Credno.40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Inactive Ingredients (mucinex Fast Max Severe Congestion & Cough) (Inactive ingredients (Mucinex Fast-Max Severe Congestion & Cough))

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum *may contain this ingredient


Advanced Ingredient Data


Raw Label Data

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