Label: MUCINEX NIGHTSHIFT SINUS MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 15, 2025

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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)


    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Triprolidine HCl 1.25 mg

  • INDICATIONS & USAGE

    Uses
    ■ 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

    Warnings
    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    ■ more than 8 caplets in 24 hours, which is the maximum
    daily amount for this product
    ■ 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 ■ 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 amotor vehicle or operatingmachinery
    Stop use and ask a doctor if
    ■ pain 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 rash or headache
    that lasts. These could be signs of a serious condition.

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ 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 SAFETY INFORMATION

    Other information
    ■ store at 20-25°C (68-77°F)

  • QUESTIONS


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

  • INACTIVE INGREDIENT

    Inactive ingredients
    croscarmellose sodium, crospovidone, hypromellose,
    microcrystalline cellulose, polyethylene glycol,
    polysorbate 80, povidone, titanium dioxide

  • PURPOSE


    Acetaminophen 325 mg ........ Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg................Cough suppressant
    Triprolidine HCl 1.25 mg...................................Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    carton label

  • INGREDIENTS AND APPEARANCE
    MUCINEX NIGHTSHIFT SINUS  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-209
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code VVV;LOGOcrescentmoonplus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-209-202 in 1 CARTON05/01/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Labeler - RB Health (US) LLC (081049410)