Label: CVS DAYTIME AND NIGHTTIME VALUE PACK COLD AND FLU- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit

  • NDC Code(s): 51316-156-24, 51316-412-12, 51316-712-12
  • Packager: CVS PHARMACY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • SPL UNCLASSIFIED SECTION

    DayTime Cold & Flu

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

    Purpose

    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 & bronchial irritation
    •
    minor aches & pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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 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 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 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, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

  • Questions?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    NIGHTTIME COLD & FLU RELIEF

  • Active ingredients (in each caplet)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Doxylamine succinate 12.5 mg
    Phenylephrine HCl 10 mg

    Purpose

    Pain reliever/Fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    •
    nasal congestion
    •
    sinus congestion & pressure
    •
    cough due to minor throat & bronchial irritation
    •
    cough to help you sleep
    •
    minor aches & pains
    •
    headache
    •
    fever
    •
    sore throat
    •
    runny nose & sneezing •reduces swelling of nasal passages
    •
    temporarily restores freer breathing through the nose
    •
    promotes nasal and/or sinus drainage
  • 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.
    •
    to make a child sleep

    When using this product

    •
    do not use more than directed
    •
    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

    •
    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 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 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, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, 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™ Severe+ VapoCOOL™

    NDC# 51316-156-24

    DayTime

    Cold & Flu

    Relief

    Acetaminophen – Pain reliever/Fever reducer

    Dextromethorphan HBr – Cough suppressant

    Guaifenesin - Expectorant

    Phenylephrine HCl – Nasal decongestant

    For Relief of

    •
    Minor Aches & Pains, Fever
    •
    Nasal Congestion & Sinus Pressure
    •
    Cough
    •
    Chest Congestion

    *Compare to the active ingredients in Vicks®NyQuil™ Severe+ VapoCOOL™

    NightTime

    Cold & Flu

    Relief

    Acetaminophen – Pain reliever/Fever reducer

    Dextromethorphan HBr – Cough suppressant

    Phenylephrine HCl - Antihistamine

    Phenylephrine HCl – Nasal decongestant

    For Relief of

    •
    Minor Aches & Pains, Fever
    •
    Nasal Congestion & Sinus Pressure
    •
    Sneezing, Runny Nose
    •
    Cough

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

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

    CVS Daytime and NightTime Cold And Flu relief 708 mL
  • INGREDIENTS AND APPEARANCE
    CVS DAYTIME AND NIGHTTIME VALUE PACK  COLD AND FLU
    acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-156
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-156-241 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2023
    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
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Item Code (Source)NDC:51316-412
    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:51316-412-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/10/2023
    Part 2 of 2
    CVS NIGHTTIME  COLD AND FLU
    acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide liquid
    Product Information
    Item Code (Source)NDC:51316-712
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 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:51316-712-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/10/2023
    Labeler - CVS PHARMACY (062312574)
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