Label: MUCINEX FAST-MAX DAY COLD AND FLU AND MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

  • NDC Code(s): 72854-241-10, 72854-241-20, 72854-241-40
  • 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 May 14, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Mucinex Fast-Max Day Cold & Flu
    Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
    Active ingredients (in each caplet)
    Mucinex Nightshift Night Severe Cold & Flu
    Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
    Triprolidine HCl 1.25 mgAntihistamine
  • Uses

    Mucinex Fast-Max Day 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

    Mucinex Nightshift Night 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
  • Warnings

    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 (Nightshift Night Severe Cold & Flu only)
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night 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)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nightshift Night Severe Cold & Flu only)

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children (Nightshift Night Severe Cold & Flu only)
    • marked drowsiness may occur (Nightshift Night Severe Cold & Flu only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Severe Cold & Flu only)
    • avoid alcoholic drinks (Nightshift Night Severe Cold & Flu only)
    • use caution when driving a motor vehicle or operating machinery (Nightshift Night Severe Cold & Flu only)

    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.

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

    Keep out of reach of children.

    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.

  • Directions

    Mucinex Fast-Max Day Cold & Flu

    • do not take more than directed (see Overdose warning)
    • do not take more than 12 caplets in any 24-hour period
    • adults and children 12 years of age and over: take 2 caplets every 4 hours
    • children under 12 years of age: do not use

    Mucinex Nightshift Night Severe Cold & Flu

    • do not take more than directed (see Overdose warning)
    • do not take more than 8 caplets in any 24-hour period
    • adults and children 12 years of age and over: take 2 caplets every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients Mucinex Fast-Max Day Cold & Flu

    croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

  • Inactive ingredients Mucinex Nightshift Night Severe Cold & Flu

    croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide

  • 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

    FAST RELEASE. POWERFUL SYMPTOM RELIEF!

    NDC 72854-241-20

    MAXIMUM STRENGTH
    Mucinex®
    FAST-MAX® NIGHTSHIFT

    DAY
    COLD & FLU
    Acetaminophen – Pain Reliever/
    Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Guaifenesin – Expectorant
    Phenylephrine HCl – Nasal Decongestant

    HEADACHE
    SORE THROAT
    CHEST CONGESTION
    BODY PAIN
    FEVER
    COUGH

    ALL IN
    ONE*

    NASAL CONGESTION
    SINUS CONGESTION
    SINUS PRESSURE

    ACTUAL SIZE

    FOR AGES 12+

    12 CAPLETS

    FAST
    RELEASE

    NIGHT
    SEVERE COLD & FLU

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

    HEADACHE
    SORE THROAT
    ITCHY THROAT
    BODY PAIN
    FEVER
    COUGH

    ALL IN
    ONE*

    NASAL CONGESTION
    SNEEZING
    RUNNY NOSE

    ACTUAL SIZE

    FOR AGES 12+

    8 CAPLETS

    TOTAL 20 CAPLETS

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX DAY COLD AND FLU AND MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-241
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-241-101 in 1 CARTON07/01/2021
    11 in 1 KIT
    2NDC:72854-241-202 in 1 CARTON07/01/2021
    21 in 1 KIT
    3NDC:72854-241-404 in 1 CARTON07/01/2021
    31 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK
    Part 21 BLISTER PACK
    Part 1 of 2
    MUCINEX FAST-MAX DAY COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (UNII: 2S7830E561)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    aluminum oxide (UNII: LMI26O6933)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    povidone, unspecified (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;MSC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2021
    Part 2 of 2
    MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (UNII: 2S7830E561)  
    ferric oxide red (UNII: 1K09F3G675)  
    hydroxypropyl cellulose, unspecified (UNII: 9XZ8H6N6OH)  
    mica (UNII: V8A1AW0880)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    polyvinyl alcohol graft polyethylene glycol copolymer (3:1; 45000 mw) (UNII: 23ZQ42JZZH)  
    povidone, unspecified (UNII: FZ989GH94E)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code VVV;LOGOcrescentmoonplus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2021
    Labeler - RB Health (US) LLC (081049410)