COLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]

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  • COLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]

COLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]
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NDC 0363-6590-08, 0363-6590-21, 0363-6590-22
Set ID 8e62c03f-1e56-459f-bcc7-dd5fd4687eb7
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each liquid-filled capsule)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg 

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant 

  • Uses

    • temporarily relieves common cold and flu symptoms:
      • sore throat
      • nasal congestion
      • headache
      • fever
      • minor aches and pains
      • cough due to minor throat and bronchial irritation 
  • 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

    • 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
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    • liver disease
    • thyroid disease
    • diabetes
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • heart disease
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin. 

    When using this product

    do not exceed recommended dosage. 

    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.

  • Directions

    • 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
  • 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 15°-30°C (59°-86°F)
    • protect from heat, humidity and light
    • see end flap for expiration date and lot number
  • Inactive ingredients

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

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

    NDC 0363-6590-21

    DAYTIME • NON-DROWSY

    Cold & Flu   

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

    MULTI-SYMPTOM

    • Relieves aches, fever, sore throat,
       nasal congestion & cough

    16
    LIQUID CAPS

    ACTUAL SIZE                                            

    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 The Procter & Gamble
    Company, owner of the registered trademark
    Vicks® DayQuil® Cold & Flu LiquiCaps®.
    50844      REV0418B65921

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

    Walgreens                   
    100% SATISFACTION
               GUARANTEED
    walgreens.com ©2017  Walgreen Co.

    PRODUCT OF CHINA. PACKAGED AND
    QUALITY ASSURED IN THE U.S.A.

    44-659

    44-659

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  DAYTIME/MULTI-SYMPTOM/NON-DROWSY
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6590
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Product Characteristics
    Colororange (clear) Scoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 659
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6590-082 in 1 CARTON03/01/201509/09/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-6590-224 in 1 CARTON03/01/201505/11/2018
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-6590-212 in 1 CARTON03/01/201509/09/2022
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/201509/09/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-6590)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-6590)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-6590)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-6590)
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