Label: CVS DAYTIME COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid

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

Drug Label Information

Updated November 2, 2023

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

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:
    nasal congestion
    sinus congestion & pressure
    cough due to minor throat and bronchial irritation
    minor aches and pains
    headache
    fever
    sore throat
    reduce swelling of nasal passages
    temporarily restores freer breathing through the nose
    promotes nasal and/or sinus drainage
    help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • Warnings

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

    more than 4 doses in 24 hrs which is maximum daily amount for this product
    taken 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 non-prescription). 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 an enlarged prostate gland
    cough that occurs with too much phlegm (mucus)
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    When using this product,

    do not use more than directed.

    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 a 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 (1-800-222-1222) 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
    only use the dose cup provided
    do not exceed 4 doses per 24 hours

    Adults & children 12 yrs & over

    30 mL every 4 hrs.

    Children 4 to under 12 yrs

    Ask a doctor

    Children under 4 yrs.

    Do not use

  • Other information

    each 30 mL contains: sodium 81 mg 
    store at room temperature. Do not refrigerate
  • Inactive ingredients

    citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to the active ingredients in VICKS® Dayquil™ Severe+ VapoCOOL™ *

    NDC 51316-727-12

    Day Time

    Cold & Flu Relief 

    Acetaminophen - Pain Reliever/Fever Reducer

    Dextromethorphan HBr - Cough Suppressant

    Phenylephrine HCI - Nasal decongestant

    For Relieves of

    Minor Aches & Pains, Fever
    Nasal congestion & Sinus Pressure
    Cough
    Chest congestion

    12 FL OZ (354 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

    Distributed by:

    *This product.is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe+ VapoCOOL™.

    CVS Daytime Severe Cold & Flu Liquid 12 Fl oz (354 mL)
  • INGREDIENTS AND APPEARANCE
    CVS DAYTIME COLD AND FLU RELIEF 
    acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-727
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-727-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/09/2023
    Labeler - CVS PHARMACY (062312574)