Label: MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

  • NDC Code(s): 63824-503-66, 63824-540-66, 72854-166-26
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 30, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

    Active ingredients (in each 20 mL)
    Mucinex Fast-Max Severe Congestion & Cough     		Purposes
    Dextromethorphan HBr 20 mgCough suppressant
    Guaifenesin 400 mgExpectorant
    Phenylephrine HCl 10 mgNasal decongestant
    Active ingredients (in each 20 mL)
    Mucinex Nightshift Cold & Flu     		Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
    Triprolidine HCl 2.5 mgAntihistamine
  • 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

    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

    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
  • 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.

    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

    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.

    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.

    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.

    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)

    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)

    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)

    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 (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.

  • 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

    MUCINEX FAST-MAX SEVERE CONGESTION & COUGH

    • 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 NIGHTSHIFT 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
  • 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

  • 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

  • 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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US), Parsippany, NJ 07054-0224

  • 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+

    carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-166
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-166-261 in 1 CARTON06/01/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    MUCINEX NIGHTSHIFT  COLD AND FLU
    acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-503
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-503-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/15/2019
    Part 2 of 2
    MUCINEX FAST-MAX  SEVERE CONGESTION AND COUGH
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-540
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-540-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)
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