Label: NIGHT TIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid

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

Drug Label Information

Updated December 29, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 30 mL dose cup or 2 tablespoons)
    Acetaminophen 650 mg 
    Dextromethorphan HBr 20 mg
    Doxylamine Succinate 12.5 mg
    Phenylephrine HCl 10 mg

  • PURPOSE

    Purpose
    Acetaminophen ...................Pain reliever/Fever reducer
    Dextromethorphan HBr........Cough suppressant
    Doxylamine Succinate .........Antihistamine
    Phenylephrine HCl ...............Nasal decongestant

  • INDICATIONS & USAGE

    Uses Temporarily relieves cold/flu symptoms: ■ nasal
    congestion ■ sinus congestion & pressure ■ sore throat
    ■ headache ■ minor aches and pain ■ runny nose and
    sneezing ■ temporarily reduces fever ■ cough due to
    minor throat and bronchial irritation ■ promotes nasal
    and/or sinus drainage

  • WARNINGS

    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 ■ 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

    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 ■ to make a child sleep.

  • OTHER SAFETY INFORMATION

    Ask a doctor before use if you have ■ a sodium
    restricted diet. liver disease ■ heart disease ■
    glaucoma ■ high blood pressure ■ thyroid disease
    ■ diabetes. 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 DOCTOR/PHARMACIST

    Ask a doctor of pharmacist before use if you are ■ taking sedatives or

    tranquilizers ■ taking the blood thinning drug warfarin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if ■ you get nervous, dizzy or sleeplessredness
    or swelling is present ■ pain, nasal congestion, or cough gets worse or lasts more
    than 7 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur
    ■ cough comes back or occurs with rash or headache that lasts. These could be
    signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ take only as recommended.  See Warnings

    ■ use dose cup or tablespoon (TBSP)

    ■ do not exceed 4 doses per 24 hours

                             Age               Dose
     Adults & children 12 years & over 30 mL (2 TBSP) every 4 hours
     Children 4 to under 12 years Ask a doctor
     Children under 4 years Do not use

    ■ do not exceed 4 doses per 24 hours

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 30 mL contains: sodium 45 mg
    ■ store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients  anhydrous citric acid, dextrose, D&C Yellow # 10, FD&C Green
    # 3, FD&C Yellow # 6, flavor, glycerin, propylene glycol, purified water,
    saccharin sodium, sodium benzoate, sodium chloride, sorbitol, xanthan gum

  • QUESTIONS

    Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

  • Product Label

    Walgreens

    Compare to Vicks® NyQuil™
    Severe Nighttime Cold & 
    Flu Relief active ingredients††

                             NDC 0363-0331-26

    NIGHTTIME

    Severe Cold & Flu

    ACETAMINOPHEN / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    DOXYLAMINE SUCCINATE / ANTIHISTAMINE
    PHENYLPHRINE HCl / NASAL DECONGESTANT

    AMAXIMUM STRENGTH

    • Pain reliever, fever reducer,
       cough suppressant, antihistamine
       & nasal decongestant

    ORIGINAL

    FLAVOR

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR TORN

    DISTRIBUTED BY WALGREEN CO., 200 WILMONT RD., DEERFIELD, IL 60015

    100 % SATISFACTION GUARANTEED walgreens.com@2020WalgreenVo.

    LR-151

    ORG1020-F

    0331-26.jpg

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  • INGREDIENTS AND APPEARANCE
    NIGHT TIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0331
    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) PHENYLEPHRINE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorgreen (Original Cough Syrup Flavor) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0331-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/13/2020
    Labeler - Walgreen Company (008965063)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(0363-0331)