Label: MUCINEX NIGHTSHIFT SEVERE COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride tablet, coated

  • NDC Code(s): 72854-234-02, 72854-234-20
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
    Triprolidine HCl 1.25 mgAntihistamine
  • Uses

    • 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

    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.

    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

    • 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

    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

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

    FAST RELEASE. POWERFUL SYMPTOM RELIEF!

    NDC 72854-234-20

    MAXIMUM STRENGTH
    Mucinex®
    NIGHTSHIFT

    SEVERE COLD & FLU

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

    ALL IN
    ONE*

    HEADACHE
    SORE THROAT
    ITCHY THROAT

    BODY PAIN
    FEVER
    COUGH

    NASAL CONGESTION

    SNEEZING
    RUNNY NOSE

    ACTUAL SIZE

    20 CAPLETS

    FOR AGES 12+

    FAST
    RELEASE

    PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX NIGHTSHIFT SEVERE COLD AND FLU  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-234
    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)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code VVV;LOGOcrescentmoonplus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-234-202 in 1 CARTON07/01/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72854-234-022 in 1 PACKET; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2021
    Labeler - RB Health (US) LLC (081049410)