Label: COLD AND FLU DAYTIME, NIGHTTIME, MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, 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 February 6, 2020

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

  • Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

    Acetaminophen 325 mg
    Dextromethorphan HBr 15 mg
    Doxylamine succinate 6.25 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    • temporarily relieves common cold and flu symptoms:
      • fever
      • headache
      • sore throat
      • minor aches and pains
      • cough due to minor throat and bronchial irritation
      • nasal congestion (Daytime only)
      • runny nose and sneezing (Nighttime only)
  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • to make a child sleepy (Nighttime only)

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • liver disease
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease (Daytime only)
    • diabetes (Daytime only)
    • thyroid disease (Daytime only)
    • high blood pressure (Daytime only)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
    • glaucoma (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)
    • avoid alcoholic beverages (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    • use caution when driving a motor vehicle or operating machinery (Nighttime only)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur (Daytime only)
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
    • pain or cough gets worse or lasts more than 7 days  (Nighttime only)
    • 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.

    If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

  • Directions (Daytime only)

    • do not take more than directed
    • do not take more than 8 capsules per 24 hours
    • adults and children 12 years and over: take 2 capsules with water every 4 hours
    • children under 12 years: ask a doctor
  • Directions (Nighttime only)

    • do not take more than directed
    • do not take more than 8 capsules per 24 hours
    • adults and children 12 years and over: take 2 capsules with water every 6 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat, humidity and light
    • see end flap for expiration date and lot number
  • Inactive ingredients (Daytime only)

    FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene
    glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
    titanium dioxide

  • Inactive ingredients (Nighttime only)

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
    glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan,
    titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    DAY & NIGHT PACK

    Walgreens

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

    DAYTIME • NON DROWSY
    Cold & Flu

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

    MULTI-SYMPTOM

    ACTUAL
    SIZE

    32
    LIQUID
    CAPS

    NIGHTTIME
    Cold & Flu

    ACETAMINOPHEN /
    PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr /
    COUGH SUPPRESSANT
    DOXYLAMINE SUCCINATE /
    ANTIHISTAMINE

    MULTI-SYMPTOM

    ACTUAL
    SIZE

    16

    LIQUID
    CAPS

    48 TOTAL LIQUID CAPS

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

    Walgreens Pharmacist Recommended
    Walgreens Pharmacist Survey

    ††This product is not manufactured or
    distributed by Procter & Gamble, owner of the
    registered trademark Vicks® DayQuil® &
    NyQuil® Cold & Flu LiquiCaps®.

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    image description

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU   DAYTIME, NIGHTTIME, MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2212
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2212-481 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product02/06/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 BLISTER PACK 32 
    Part 22 BLISTER PACK 16 
    Part 1 of 2
    COLD AND FLU   DAYTIME, MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, phenylephrine hcl 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
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (Softgels) Size21mm
    FlavorImprint Code 512
    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 finalpart34102/06/2020
    Part 2 of 2
    COLD AND FLU   NIGHTTIME, MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate 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 HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 215
    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 finalpart34103/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/06/2020
    Labeler - Walgreens (008965063)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PVT LTD677385498manufacture(0363-2212)