Label: SEVERE COLD AND FLU DAYTIME NON DROWSY AND NIGHTTIME- acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 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 October 29, 2021

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

  • DAYTIME SEVERE COLD AND FLU

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients (in each softgel)                                Purposes
    Acetaminophen 325 mg............................Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg.............................Cough suppressant
    Guaifenesin 200 mg.........................................................Expectorant
    Phenylephrine HCl 5 mg......................................Nasal decongestant

  • Uses

    ■ temporarily relieves common cold/flu symptoms:
    ■ nasal congestion ■ sinus congestion & pressure
    ■ cough due to minor throat & bronchial irritation
    ■ minor aches & pains ■ headache
    ■ fever ■ sore throat ■ 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.

  • 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

    Drug Facts (continued)

    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
    ■ trouble urinating due to enlarged prostate gland
    ■ cough that occurs with too much phlegm (mucus)
    ■ persistent or chronic cough such as occurs with smoking,
    asthma, chronic bronchitis, or emphysema

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood
    thinning drug warfarin.

  • WHEN USING

    When using this product, do not use more than directed.

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)

    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.

  • PREGNANCY OR BREAST FEEDING

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

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious
    health problems. 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 - see Overdose warning
    ■ do not exceed 4 doses per 24 hours

     adults & children 12 years & over 2 softgels with water every
    4 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use

    ■ when using other Nighttime or Daytime products, carefully read
    each label to ensure correct dosing

  • Other information

    ■ store at room temperature

  • Inactive ingredients

    FD&C Yellow # 6, gelatin, glycerin,
    polyethylene glycol, povidone, propylene glycol, purified water,
    sorbitol sorbitan , titanium dioxide

  • SPL UNCLASSIFIED SECTION

    NIGHTTIME SEVERE COLD & FLU SOFTGELS

    Drug Facts

    Active ingredients (in each softgel)                              Purposes
    Acetaminophen 325 mg............................Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg.............................Cough suppressant
    Doxylamine succinate 6.25 mg.....................................Antihistamine
    Phenylephrine HCl 5 mg......................................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.

  • NIGHTTIME SEVERE COLD & FLU SOFTGELS

    Drug Facts (continued)

  • 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

  • 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

  • NIGHTTIME SEVERE COLD & FLU SOFTGELS

    Drug Facts (continued)

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious
    health problems. 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 - see Overdose warning
    ■ do not exceed 4 doses per 24 hours

     adults & children 12 years & over 2 softgels with water every
    4 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use

  • Other information

    store at room temperature

  • Inactive ingredients

    D&C Yellow# 10, FD&C Blue# 1, gelatin,
    glycerin, polyethylene glycol, povidone, propylene glycol, purified
    water, sorbitol sorbitan, sodium hydroxide*, titanium dioxide
    * may contain this ingredient

  • Questions or comments?

    Call toll free: 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    DAY & NIGHT PACK

    Walgreens

    Compare to Vicks® DayQuil® Severe

    Cold & Flu & 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

    32SOFTGELS

    NIGHTTIME

    Severe

    Cold & Flu

    ACETAMINOPHEN /

    PAIN RELIEVER / FEVER REDUCER

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    DOXYLAMINE SUCCINATE / ANTIHISTAMINE

    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    ACTUAL SIZE

    16SOFTGELS

    48 SOFTGELS

    DT-NT SVR

  • INGREDIENTS AND APPEARANCE
    SEVERE COLD AND FLU  DAYTIME NON DROWSY AND NIGHTTIME
    acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8994
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8994-481 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/23/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32 
    Part 22 BLISTER PACK 16 
    Part 1 of 2
    DAYTIME SEVERE COLD AND FLU  NON-DROWSY
    acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL (OBLONG) Size20mm
    FlavorImprint Code 341;908
    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 finalpart34108/23/2021
    Part 2 of 2
    NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVAL (OBLONG) Size20mm
    FlavorImprint Code 116;A07
    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 finalpart34108/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/23/2021
    Labeler - Walgreens (008965063)