Maximum Strength Mucinex® Fast-max ®

Maximum Strength Mucinex® Fast-max ®
SPL v5
SPL
SPL Set ID 3ba3548e-85e7-b4a6-e063-6394a90af84d
Route
ORAL
Published
Effective Date 2022-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg) Triprolidine (2.5 mg) Guaifenesin (400 mg)
Inactive Ingredients
Glycerin 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
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 COLD & FLU
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Active ingredients (in each 20 mL)

MUCINEX NIGHTSHIFT SEVERE COLD & FLU
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
Triprolidine HCl 2.5 mg Antihistamine
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.
Questions?

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

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.

Liver Warning

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
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.

Other Information
  • each 20 mL contains: sodium 12 mg (Fast-Max Cold & Flu only) and sodium 16 mg (Nightshift Severe Cold & Flu only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
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.

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
  • marked drowsiness may occur (Nightshift Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only)
Mucinex Fast Max Cold & Flu
  • 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Nightshift Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Severe 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)
Mucinex Nightshift Severe Cold & Flu
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Principal Display Panel Kit Carton

NDC 72854-154-26

DAY & NIGHT COLD & FLU PACK



Mucinex®



FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

SORE THROAT



FEVER



HEADACHE



BODY PAIN



ALL IN



ONE*



CHEST CONGESTION



COUGH



NASAL CONGESTION



SINUS CONGESTION



SINUS PRESSURE

FOR



AGES 12+



TWO – 6 FL OZ (180 mL) bottles

MAXIMUM STRENGTH



Mucinex®



NIGHTTIME

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – Antihistamine

SORE THROAT



FEVER



HEADACHE



BODY PAIN



ALL IN



ONE*



ITCHY THROAT



COUGH



NASAL CONGESTION



SNEEZING



RUNNY NOSE

TOTAL – 12 FL OZ (360 mL)



FOR



AGES 12+

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nightshift Severe Cold & Flu only)
Inactive Ingredients (mucinex Fast Max Cold & Flu)

ammonium glycyrrhizate, anhydrous citric acid, edetate

disodium, FD&C blue no. 1, FD&C red no. 40, flavor,

glycerin, propyl gallate, propylene glycol, purified

water, sodium benzoate, sorbitol, sucralose,

trisodium citrate dihydrate†, xanthan gum

†may contain this ingredient

Inactive Ingredients (mucinex Nightshift Severe Cold & Flu)

ammonium glycyrrhizate, anhydrous citric acid, ascorbic

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

red no. 40, flavors, glycerin (soy), propylene

glycol, sodium benzoate, sorbitol, sucralose,

triacetin, triethyl citrate, water, xanthan gum


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 COLD & FLU
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Active ingredients (in each 20 mL)

MUCINEX NIGHTSHIFT SEVERE COLD & FLU
Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Phenylephrine HCl 10 mg Nasal decongestant
Triprolidine HCl 2.5 mg Antihistamine
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.
  • 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.

Allergy Alert (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.

Liver Warning (Liver warning)

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
Overdose Warning (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.

Other Information (Other information)
  • each 20 mL contains: sodium 12 mg (Fast-Max Cold & Flu only) and sodium 16 mg (Nightshift Severe Cold & Flu only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Sore Throat Warning (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.

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
  • marked drowsiness may occur (Nightshift Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only)
Mucinex Fast Max Cold & Flu (MUCINEX FAST-MAX COLD & FLU)
  • 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Nightshift Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Severe 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)
Mucinex Nightshift Severe Cold & Flu (MUCINEX NIGHTSHIFT SEVERE COLD & FLU)
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

NDC 72854-154-26

DAY & NIGHT COLD & FLU PACK



Mucinex®



FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

SORE THROAT



FEVER



HEADACHE



BODY PAIN



ALL IN



ONE*



CHEST CONGESTION



COUGH



NASAL CONGESTION



SINUS CONGESTION



SINUS PRESSURE

FOR



AGES 12+



TWO – 6 FL OZ (180 mL) bottles

MAXIMUM STRENGTH



Mucinex®



NIGHTTIME

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer



Dextromethorphan HBr – Cough Suppressant



Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – Antihistamine

SORE THROAT



FEVER



HEADACHE



BODY PAIN



ALL IN



ONE*



ITCHY THROAT



COUGH



NASAL CONGESTION



SNEEZING



RUNNY NOSE

TOTAL – 12 FL OZ (360 mL)



FOR



AGES 12+

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
  • taking sedatives or tranquilizers (Nightshift Severe Cold & Flu only)
Inactive Ingredients (mucinex Fast Max Cold & Flu) (Inactive ingredients (MUCINEX FAST-MAX COLD & FLU))

ammonium glycyrrhizate, anhydrous citric acid, edetate

disodium, FD&C blue no. 1, FD&C red no. 40, flavor,

glycerin, propyl gallate, propylene glycol, purified

water, sodium benzoate, sorbitol, sucralose,

trisodium citrate dihydrate†, xanthan gum

†may contain this ingredient

Inactive Ingredients (mucinex Nightshift Severe Cold & Flu) (Inactive ingredients (MUCINEX NIGHTSHIFT SEVERE COLD & FLU))

ammonium glycyrrhizate, anhydrous citric acid, ascorbic

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

red no. 40, flavors, glycerin (soy), propylene

glycol, sodium benzoate, sorbitol, sucralose,

triacetin, triethyl citrate, water, xanthan gum


Advanced Ingredient Data


Raw Label Data

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