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

  • Category: HUMAN OTC DRUG LABEL

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 December 9, 2020

If you are a healthcare professional or from the pharmaceutical industry 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

    res

  • 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 finalpart34111/13/2020
    Labeler - Walgreen Company (008965063)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(0363-0331)