Label: CVS DT AND NT COMBO PACK COLD AND FLU- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit

  • NDC Code(s): 51316-618-12, 51316-619-12, 51316-620-12
  • Packager: CVS PHARMACY
  • 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.

View All Sections
  • SPL UNCLASSIFIED SECTION

    CVS DayTime Cold & Flu Relief

  • 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/flu symptoms:
    •
    nasal congestion
    •
    cough due to minor throat & bronchial irritation
    •
    minor aches & pains
    •
    headache
    •
    fever
    •
    sore throat
  • Warnings

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take

    •
    adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
    •
    child takes more than 4 doses (15 mL each) 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 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.

    Ask a doctor before use if you have

    •
    Liver disease
    •
    Heart disease
    •
    High blood pressure
    •
    Thyroid disease
    •
    Diabetes
    •
    Trouble urinating due to 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 (adult)
    •
    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 overdose, get medical help or contact a Poison Control Center 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 hrs

    adults & children 12 yrs & over

    30 mL every 4 hours

    Children 6 to under 12 yrs

    15 mL every 4 hours

    children 4 to under 12 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, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    CVSNIGHTTIME COLD & FLU RELIEF

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 30 mg
    Doxylamine succinate 12.5 mg

    Purpose

    Pain reliever/Fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    cough due to minor throat & bronchial irritation
    •
    minor aches & pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    runny nose & sneezing
  • Warnings

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take

    •
    more than 4 doses in 24 hours, which is the 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 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.

    Ask a doctor before use if you have

    •
    Liver disease
    •
    glaucoma
    •
    Trouble urinating due to enlarged prostate gland
    •
    Cough that occurs with too much phlegm (mucus)
    •
    A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are

    •
    Taking sedatives or tranquilizers
    •
    Taking the blood thinning drug warfarin

    When using this product

    •
    excitability may occur, especially in children
    •
    marked drowsiness may occur
    •
    avoid alcoholic drinks
    •
    be careful when driving a motor vehicle or operating machinery
    •
    alcohol, sedatives & tranquilizers may increase drowsiness

    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 overdose, get medical help or contact a Poison Control Center 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 hrs

    adults & children 12 yrs & over

    30 mL every 4 hours

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    •
    each 30 mL contains: sodium 16 mg
    •
    Store at room temperature
    •
    Do not refrigerate
  • Inactive ingredients

    Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Distributed By:

  • PRINCIPAL DISPLAY PANEL - Kit Carton

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

    NDC# 51316-618-12

    DayTime

    Cold & Flu

    Relief

    Acetaminophen, Dextromethorphan HBr,

    Phenylephrine HCl

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

    Compare to the active ingredients in Vicks®NyQuil™ Cold & Flu*

    NightTime

    Cold & Flu

    Relief

    Acetaminophen, Dextromethorphan HBr

    Dextromethorphan HBr

    •
    headache, Fever, Sore Throat,
    •
    Minor Aches & Pains
    •
    Sneezing, Runny Nose
    •
    Cough

    Original Flavor

    Tamper Evident: Do not use if imprinted shrink band is missing or broken.

    TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)

    *These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ and Vicks® Nyquil™ Cold & flu.

    CVS Daytime and NightTime Cold And Flu relief 708 mL (COMBO PACK)
  • INGREDIENTS AND APPEARANCE
    CVS DT AND NT COMBO PACK  COLD AND FLU
    acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-618
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-618-121 in 1 PACKAGE; Type 0: Not a Combination Product03/20/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 354 mL
    Part 21 BOTTLE 354 mL
    Part 1 of 2
    CVS DAYTIME COLD AND FLU  RELIEF
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
    Product Information
    Item Code (Source)NDC:51316-620
    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 (UNII: EE90ONI6FF)  
    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:51316-620-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/20/2023
    Part 2 of 2
    CVS NIGHTTIME COLD AND FLU  RELIEF
    acetaminophen, doxylamine succinate, and dextromethorphan hydrobromide liquid
    Product Information
    Item Code (Source)NDC:51316-619
    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 HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 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 GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-619-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/20/2023
    Labeler - CVS PHARMACY (062312574)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!