Label: NYQUIL SEVERE- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated

  • 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 November 21, 2019

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

  • Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:
    • nasal congestion • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation • cough to help you sleep
    • minor aches & pains • headache • fever • sore throat
    • runny nose & sneezing • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 4 doses in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day 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 • high blood pressure • thyroid disease • diabetes 
    • glaucoma • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

    When using this product

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

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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 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.

    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

    take only as directed do not exceed 4 doses per 24 hrs

     adults & children 12 yrs & over 2 caplets with water every 4 hrs
     children 4 to under 12 yrs ask a doctor
     children under 4 yrs do not use

  • Other information

    • store at room temperature

  • Inactive ingredients

    crospovidone, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, magnesium stearate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions?

    1-800-362-1683

  • Package Labeling:

    NyQuil

  • INGREDIENTS AND APPEARANCE
    NYQUIL SEVERE 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-159(NDC:37000-523)
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code NQ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-159-011 in 1 CARTON09/21/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-159-021 in 1 CARTON09/21/2016
    24 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/21/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-159)