Label: COLD AND FLU DAYTIME, NIGHTTIME, MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit

  • 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 December 9, 2021

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

  • Active ingredients (in each caplet) (Daytime Severe Cold & Flu)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Active ingredients (in each caplet) (Nighttime Severe Cold & Flu)

    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 and flu symptoms:
      • minor aches and pains
      • nasal congestion
      • headache
      • fever
      • sore throat
      • sinus congestion and pressure
      • cough due to minor throat and bronchial irritation
      • runny nose and sneezing (Nighttime only)
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • with other drugs containing acetaminophen
    • more than 4,000 mg of acetaminophen in 24 hours
    • 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

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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
    • diabetes
    • high blood pressure
    • glaucoma (Nighttime only)
    • thyroid disease
    • heart disease
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • avoid alcoholic beverages (Nighttime only)
    • be careful when driving a motor vehicle or operating machinery (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

    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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

  • Directions

    • do not take more than directed
    • do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period
    • adults and children 12 years and over: take 2 caplets with water every 4 hours
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients (Daytime only)

    corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Inactive ingredients (Nighttime only)

    black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    DAY & NIGHT PACK

    NDC 0363-6406-08

    Walgreens

     Compare to Vicks® DayQuil® Severe
    Cold & Flu and Vicks® NyQuil® Severe
    Cold & Flu active ingredients††

    DAYTIME • NON-DROWSY

    Severe
    Cold & Flu

    ACETAMINOPHEN /
    PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    GUAIFENESIN / EXPECTORANT
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    ACTUAL
    SIZE

    16 CAPLETS

    NIGHTTIME

    Severe
    Cold & Flu

    ACETAMINOPHEN /
    PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    DOXYLAMINE SUCCINATE / ANTIHISTAMINE
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    ACTUAL
    SIZE

    CAPLETS

    24 TOTAL CAPLETS

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
    BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF
    TAMPERING

    Walgreens
    Trusted since 1901™
    PHARMACIST
    RECOMMENDED

    Walgreens Pharmacist Survey
    ††This product is not manufactured or distributed by
    The Procter & Gamble Company, owner of the
    registered trademark Vicks® DayQuil® Severe Cold &
    Flu and Vicks® NyQuil® Severe Cold & Flu.
    50844                     REV0519B64067708

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    Walgreens
    100 % SATISFACTION
    GUARANTEED
    walgreens.com   ©2017 Walgreen Co.

    Walgreens 44-640677-08

    Walgreens 44-640677-08

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  DAYTIME, NIGHTTIME, MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6406
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6406-081 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 21 BLISTER PACK
    Part 1 of 2
    COLD AND FLU  DAYTIME, MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;640
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/27/2014
    Part 2 of 2
    COLD AND FLU  NIGHTTIME, MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
    Product Information
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;677
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2015
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-6406)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-6406)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-6406)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-6406)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-6406)