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

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

Drug Label Information

Updated August 20, 2024

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

  • Active ingredients (in each 15 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

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

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

    • adult takes more than 4 doses (30 mL) in 24 hrs which is maximum daily amount for this product
    • child takes more than 4 doses (15 mL) in 24 hours, which is the maximum daily amount for this product
    • 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 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 5 days (children) or 7 days (adults) 
    • 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 6 to under 12 yrs

    15 mL every 4 hrs

    Children 4 to under 6 yrs

    Ask a doctor

    Children under 4 yrs.

    Do not use

  • Other information

    • each 15 mL contains: sodium 42 mg 
    • store at room temperature. Do not refrigerate
  • Inactive ingredients

    Anhydrous citric acid, disodium edetate, FD&C Yellow No 6, flavors, glycerin, menthol, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare tothe active ingredients in VICKS® Dayquil™ Cold & Flu*

    NDC 51316-617-12

    Day Time

    Cold & Flu Relief 

    Acetaminophen,Phenylephrine HCI,

    Dextromethorphan HBr

    For Relieves of

    • Headache, Fever, Sore Throat, Minor Aches & Pains
    • Nasal congestion & Sinus Pressure
    • Cough

    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™ Cold & Flu.

    CVS Daytime  Cold & Flu Liquid 12 Fl oz (354 mL)
  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU RELIEF 
    acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-617
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-617-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/13/2023
    Labeler - CVS PHARMACY (062312574)