COLD AND FLU NIGHTTIME/MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]

COLD AND FLU NIGHTTIME/MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]
PDF | XML

NDC 0363-6600-08, 0363-6600-21
Set ID e365e776-b695-4ef6-9a3d-f4f0285089b0
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each liquid-filled capsule)

    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:
      • sore throat
      • minor aches and pains
      • fever
      • headache
      • runny nose and sneezing
      • 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
    • to make a child sleepy
    • 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
    • glaucoma
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • 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
    • taking sedatives or tranquilizers 

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • avoid alcoholic beverages
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery 

    Stop use and ask a doctor if

    • pain 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 6 hours
    • children under 12 years: ask a doctor
  • Other information

    • protect from heat, humidity and light
    • 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)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

  • Questions or comments?

    1-800-426-9391 

  • Principal Display Panel

    Walgreens

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

     NDC 0363-6600-08

    NIGHTTIME
    Cold & Flu                              

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

    MULTI-SYMPTOM   

    • Relieves aches, fever, sore throat, sneezing, runny nose & cough

    24
    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® NyQuil® Cold & Flu LiquiCaps®.

    50844    REV0418B66008

    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.

    Walgreens 44-660

    Walgreens 44-660

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  NIGHTTIME/MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6600
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorgreen (clear) Scoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 660
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6600-082 in 1 CARTON03/01/201502/06/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-6600-212 in 1 CARTON03/01/201502/06/2022
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/201502/06/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-6600)

Related Drugs