Label: SEVERE COLD PLUS FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 12, 2023

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

  • SPL UNCLASSIFIED SECTION


    SEVERE COLD + FLU DAYTIME

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes

    Acetaminophen 500 mg

    Pain reliever/fever reducer

    Dextromethorphan hydrobromide 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Phenylephrine hydrochloride 10 mg

    Nasal decongestant

  • Uses

    temporarily relieves these symptoms due to a cold or flu:
    minor aches and pains
    headache
    sore throat
    cough
    nasal congestion
    sinus congestion and pressure
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    temporarily reduces fever
  • Warnings

    Liver warning

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

    more than 6 packets in 24 hours, which is the maximum daily amount for this product
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    ALLERGY ALERT

     
    Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
    Skin reddening
    Blisters

    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
    in children under 12 years of age

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    pain, cough, or nasal congestion 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.
    nervousness, dizziness, or sleeplessness occurs

    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 at 1-800-222-1222. Quick 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 the recommended dose
    take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
    adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    children under 12 years: do not use
  • Other information

    each packet contains: potassium 6 mg
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

  • Questions or comments?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    SEVERE COLD + FLU NIGHTTIME

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan hydrobromide 20 mg

    Cough suppressant

    Doxylamine succinate 12.5 mg

    Antihistamine

    Phenylephrine hydrochloride 10 mg

    Nasal decongestant

  • Uses

    temporarily relieves these symptoms due to a cold or flu:
    headache
    minor aches and pains
    cough
    sore throat
    nasal congestion
    sinus congestion and pressure
    runny nose
    sneezing
    temporarily reduces fever
  • Warnings

    Liver warning

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

    more than 5 packets in 24 hours, which is the maximum daily amount for this product
    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

    Is a skin or general allergic 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 to sedate children.

    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
    in children under 12 years of age

    Ask a doctor before use if you have

    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    glaucoma
    cough with excessive phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    difficulty in urination due to enlargement of the prostate gland
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin
    taking sedatives or tranquilizers

    When using this product

    do not exceed recommended dosage
    may cause marked drowsiness
    avoid alcoholic drinks
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery
    excitability may occur, especially in children

    Stop use and ask a doctor if

    pain, cough, or nasal congestion 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.
    nervousness, dizziness, or sleeplessness occurs

    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 at 1-800-222-1222. Quick 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 the recommended dose
    take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
    adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    children under 12 years: do not use
  • Other information

    each packet contains: potassium 6 mg
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL-

    Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*

    DAYTIME

    SEVERE COLD & FLU

    Acetaminophen / Pain reliever-fever reducer

    Dextromethorphan HBr / Cough suppressant

    Guaifenesin / Expectorant
    Phenylephrine HCl / Nasal decongestant

    Relieves:
    • Nasal Congestion • Headache
    • Sore Throat • Body Ache • Cough
    • Mucus • Chest Congestion • Fever

    Honey Lemon Flavor

    Naturally and Artificially Flavored

    NIGHTTIME

    Severe Cold & Flu

    Acetaminophen / Pain reliever-fever reducer

    Dextromethorphan HBr / Cough suppressant
    Doxylamine succinate / Antihistamine
    Phenylephrine HCl / Nasal decongestant

    Relieves:

    • Nasal Congestion • Headache
    • Sore Throat • Body Ache
    • Cough • Runny Nose • Fever

    Honey Lemon Flavor

    Naturally and Artificially Flavored

    TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN

    DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

    6 DAY PACKETS + 6 NIGHT PACKETS
    12 TOTAL

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive Woonsocket, RI 02895

    ©2017 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    Money Back Guarantee

    *These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.

    Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor
  • INGREDIENTS AND APPEARANCE
    SEVERE COLD PLUS FLU DAYTIME NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-546
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-546-121 in 1 CARTON; Type 0: Not a Combination Product07/14/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CARTON
    Part 21 CARTON
    Part 1 of 2
    SEVERE COLD PLUS FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/14/2017
    Part 2 of 2
    SEVERE COLD PLUS FLU NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/14/2017
    Labeler - CVS Pharmacy,Inc. (062312574)