Label: MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kit

  • NDC Code(s): 72854-138-66, 72854-139-26, 72854-140-66
  • 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 9, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    KICKSTART SEVERE COLD & FLU:

    Acetaminophen 650mg.................................Pain reliever/fever reducer
    Dextromethorphan HBr 20 mg.....................................Cough suppressant
    Guaifenesin 400 mg........................................................Expectorant
    Phenylephrine HCl 10mg........................................Nasal decongestant

    NIGHT TIME SEVERE COLD & FLU:

    Acetaminophen 650mg............................ ....Pain reliever/fever reducer
    Dextromethorphan HBr 20 mg....................................Cough suppressant
    Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
    Triprolidine HCl 2.5 mg................................................Antihistamine

  • Uses

    KICKSTART SEVERE 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

    NIGHT TIME SEVERE 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

  • Warnings

    KICKSTART SEVERE COLD & FLU:

    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.
    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.

    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 fever, rash, or headache that lasts. These could
    be signs of a serious condition.

    NIGHT TIME SEVERE COLD & FLU:

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if
    you take:
    ■ more than 4,000 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: 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: 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.
    ■ 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

    ■ glaucoma

    ■ trouble urinating due to an enlarged prostate gland
    ■ a breathing problem such as emphysema or chronic bronchitis
    ■ persistent or chronic cough such as occurs with smoking, asthma, 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
    ■ taking sedatives or tranquilizers


    When using this product

    ■ do not use more than directed
    ■ excitability may occur, especially in children
    ■ marked drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase drowsiness
    ■ avoid alcoholic drinks
    ■ use caution when driving a motor vehicle or operating machinery


    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.

  • Directions

    KICKSTART SEVERE COLD & FLU

    ■ 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
    over: 20 mL in dosing cup provided
    every 4 hours
    ■ children under 12 years of age: do not use

    NIGHT TIME SEVERE 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

    KICKSTART SEVERE COLD & FLU

    ■ each 20 mL contains: sodium 12 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

    NIGHT TIME SEVERE COLD & FLU

    ■ each 20 mL contains: sodium 16 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

  • INACTIVE INGREDIENT

    KICKSTART SEVERE COLD & FLU

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

    NIGHT TIME 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

  • QUESTIONS

    1-866-MUCINEX
    (1-866-682-4639)

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding, ask a health
    professional before use.
    Keep out of reach of children.

  • Purposes

    KICKSTART SEVERE COLD & FLU:

    Dextromethorphan HBr 20 mg.....................................Cough suppressant
    Guaifenesin 400 mg........................................................Expectorant
    Phenylephrine HCl 10mg........................................Nasal decongestant

    NIGHT TIME SEVERE COLD & FLU:

    Dextromethorphan HBr 20 mg....................................Cough suppressant
    Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
    Triprolidine HCl 2.5 mg................................................Antihistamine

  • PRINCIPAL DISPLAY PANEL

    NDC 72854-139

    MUCINEX FAST-MAX Kickstart + Nighttime Cold & Flu Pack

    Kickstart Severe Cold & Flu:

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

    Nighttime Severe Cold & Flu:

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – Antihistamine

    FOR
    AGES 12+
    TWO – 6 FL OZ (180 mL) bottles

    TOTAL – 12 FL OZ (360 mL)

    LabelLabelLabelLabel

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-139
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-139-261 in 1 CARTON05/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:72854-138
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-138-66180 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 finalpart34105/01/2023
    Part 2 of 2
    MUCINEX NIGHT TIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:72854-140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-140-66180 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 finalpart34105/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2023
    Labeler - RB Health (US) LLC (081049410)