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

  • NDC Code(s): 63824-117-66, 63824-503-66, 63824-540-66
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 8, 2023

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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 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

    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 (Nightshift Cold & Flu Clear & Cool 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 Clear & Cool 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 Clear & Cool 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 Nightshift Cold & Flu Clear & Cool
    ■ 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 Clear &
    Cool only) and sodium 16 mg
    (Nightshift Cold & Flu Clear &
    Cool only)
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

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

    anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

    1
    may contain this ingredient
  • Inactive ingredients (Mucinex Nightshift 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

  • 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 63824-117-66

    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®
    NIGHTSHIFT

    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+

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-117
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-117-661 in 1 CARTON06/30/2022
    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 finalpart34106/15/2019
    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 finalpart34101/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/24/2019
    Labeler - RB Health (US) LLC (081049410)
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