Label: COLD AND FLU DAY- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Active ingredients (in each 15 mL)

    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
      • minor aches and pains
      • cough due to minor throat and bronchial irritation
      • headache
    • temporarily reduces fever
  • Warnings

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

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 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

    Ask a doctor before use if the user has

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

    Ask a doctor or pharmacist before use if the user is

    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
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • 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 overdose, get medical help or contact a Poison Control Center 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 exceed 4 doses per 24 hours
    • mL = milliliter
    • only use the dose cup provided
    adults and children 12 years and over30 mL every 4 hours
    children 6 to under 12 years15 mL every 4 hours
    children under 6 yearsdo not use
  • Other information

    • each 15 mL contains: sodium 13 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    NDC 0363-9912-02

    Walgreens

    WALGREENS PHARMACIST RECOMMENDED†

    Compare to the active ingredients
    in Vicks® DayQuil® Cold & Flu††

    DAY
    Cold & Flu

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

    • Relieves headaches, fever,
    sore throat, minor aches
    & pains, cough

    • Nasal congestion

    Ages 6 Years and Over

    Menthol
    flavor

    12 FL OZ (355 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    Do Not Take
    Daytime and
    Nighttime
    Products at the
    Same Time.

    †Our pharmacists recommend the Walgreens brand.
    We invite you to compare to national brands.
    ††This product is not manufactured or distributed by The Procter & Gamble
    Company, owner of the registered trademark Vicks® DayQuil® Cold & Flu.

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com     ©2022 Walgreen Co.

    50844   REV0323A01202

    Walgreens 44-012

    Walgreens 44-012

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  DAY
    acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9912
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9912-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/14/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(0363-9912) , pack(0363-9912)
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