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

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

    Mucinex Fast-Max Day 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 impulse to cough to help you get to sleep
      • the intensity of coughing
      • nasal congestion due to a cold

    Mucinex Nightshift Night 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 Night Cold & Flu only)

    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 (Nightshift Night 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 Night 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 Night 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 Night Cold & Flu only)
    • heart disease (Fast-Max Day Severe Congestion & Cough only)
    • high blood pressure (Fast-Max Day Severe Congestion & Cough only)
    • thyroid disease (Fast-Max Day Severe Congestion & Cough only)
    • diabetes (Fast-Max Day Severe Congestion & Cough only)
    • glaucoma (Nightshift Night Cold & Flu only)
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night 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 Night Cold & Flu only)
    • taking sedatives or tranquilizers (Nightshift Night Cold & Flu only)

    When using this product

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

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 7 days (Nightshift Night Cold & Flu only)
    • fever gets worse or lasts more than 3 days (Nightshift Night Cold & Flu only)
    • redness or swelling is present (Nightshift Night Cold & Flu only)
    • new symptoms occur (Nightshift Night Cold & Flu only)
    • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Night Cold & Flu only)
    • nervousness, dizziness, or sleeplessness occur (Fast-Max Day Severe Congestion & Cough only)
    • symptoms do not get better within 7 days or occur with fever (Fast-Max Day 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 Day 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 Night 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 Day Severe Congestion & Cough

    • do not take more than directed
    • 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 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 Severe Congestion & Cough

    croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

  • Inactive ingredients Mucinex Nightshift Night Cold & Flu

    croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, 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 72854-242-40

    MAXIMUM STRENGTH
    Mucinex®
    FAST-MAX® NIGHTSHIFT

    DAY
    SEVERE CONGESTION
    & COUGH

    Dextromethorphan HBr – Cough Suppressant
    Guaifenesin – Expectorant
    Phenylephrine HCl – Nasal Decongestant

    Controls Cough
    Relieves Nasal & Chest
    Congestion
    Thins & Loosens Mucus

    ACTUAL SIZE

    FOR AGES 12+

    24 CAPLETS

    NIGHT
    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

    ACTUAL SIZE

    FOR AGES 12+

    16 CAPLETS

    FAST
    RELEASE

    TOTAL 40 CAPLETS

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX DAY SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT NIGHT COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-242
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-242-401 in 1 CARTON07/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 24 
    Part 24 BLISTER PACK 16 
    Part 1 of 2
    MUCINEX FAST-MAX DAY SEVERE CONGESTION AND COUGH   MAXIMUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    aluminum oxide (UNII: LMI26O6933)  
    mica (UNII: V8A1AW0880)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    povidone, unspecified (UNII: FZ989GH94E)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;SCC
    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 COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, 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
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (UNII: 2S7830E561)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    povidone, unspecified (UNII: FZ989GH94E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code VVV;LOGOcrescentmoon
    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)