Label: WALGREEN NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine hydrochloride solution

  • 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 4, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Doxylamine succinate 12.5 mg
    Phenylephrine HCl 10 mg

    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
    a sodium-restricted diet

    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 at 1-800-222-1222 . 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
    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use


  • Other information

    each 30 mL contains: sodium 81 mg
    Store at room temperature. Do not refrigerate.
  • Inactive ingredients

    citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Distributed by:

  • PRINCIPAL DISPLAY PANEL - 354mL Bottle Label

    *Compare to the active ingredients in VICKS® NyQuil™ Severe + VapoCOOL™

    NDC 0363-6142-12

    NightTime
    Cold & Flu Relief

    Acetaminophen- Pain reliever/Fever reducer

    Dextromethorphan HBr – Cough suppressant

    Doxylamine Succinate - Antihistamine

    Phenylephrine HCl – Nasal decongestant
    For Relief of

    Minor Aches & Pains, Fever
    Nasal Congestion & Sinus Pressure
    Sneezing, Runny Nose
    Cough

    For Ages 12+

    12 FL OZ (354 ml)

    Walgreen NightTime Cold & Flu Cold Relief 12 FL OZ
  • INGREDIENTS AND APPEARANCE
    WALGREEN NIGHTTIME  COLD AND FLU RELIEF
    acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6142
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6142-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/17/2023
    Labeler - WALGREENS CO. (008965063)