Label: MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl 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

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  • Active ingredients (in each packet) – Multi Symptom Severe Cold

    Acetaminophen 500 mg

    Dextromethorphan hydrobromide 20 mg

    Phenylephrine hydrochloride 10 mg

  • Active ingredients (in each packet) - Nighttime Severe Cold and Cough

    Acetaminophen 650 mg

    Diphenhydramine hydrochloride 25 mg

    Phenylephrine hydrochloride 10 mg

  • Purpose - Multi Symptom Severe Cold

    Pain reliever/fever reducer

    Cough Suppressant

    Nasal Decongestant

  • Purpose - Nighttime Severe Cold and Cough

    Pain reliever/fever reducer

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses - Multi Symptom Severe Cold

    ▪
    temporarily relieves these symptoms due to a cold:
    ▪
    minor aches and pains
    ▪
    minor sore throat pain
    ▪
    headache
    ▪
    nasal and sinus congestion
    ▪
    cough due to minor throat and bronchial irritation
    ▪
    temporarily reduces fever
  • Uses - Nighttime Severe Cold and Cough

    ▪
    temporarily relieves these symptoms due to a cold:
    ▪
    minor aches and pains
    ▪
    minor sore throat pain
    ▪
    headache
    ▪
    nasal and sinus congestion
    ▪
    runny nose
    ▪
    sneezing
    ▪
    itchy nose or throat
    ▪
    itchy, watery eyes due to hay fever
    ▪
    cough due to minor throat and bronchial irritation
    ▪
    temporarily reduces fever
  • Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

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

    ▪
    more than 4,000 mg of acetaminophen in 24 hours
    ▪
    with other drugs containing acetaminophen
    ▪
    3 or more alcoholic drinks every day while using this product

    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 - Multi Symptom Severe Cold

    ▪
    in a child under 12 years of age
    ▪
    if you are allergic to acetaminophen
    ▪
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.
  • Do not use - Nighttime Severe Cold and Cough

    ▪
    in a child under 12 years of age
    ▪
    if you are allergic to acetaminophen
    ▪
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
    ▪
    with any other product containing diphenhydramine, even one used on skin
    ▪
    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 - Multi Symptom Severe Cold

    ▪
    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)
    ▪
    cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • Ask a doctor before use if you have - Nighttime Severe Cold and Cough

    ▪
    liver disease
    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    thyroid disease
    ▪
    diabetes
    ▪
    glaucoma
    ▪
    a sodium restricted diet
    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    a breathing problem such as emphysema or chronic bronchitis
    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • Ask a doctor or pharmacist before use if you are - Multi Symptom Severe Cold

    taking the blood thinning drug warfarin

  • Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough

    ▪
    taking sedatives or tranquilizers
    ▪
    taking the blood thinning drug warfarin
  • When using this product - Multi Symptom Severe Cold

    do not exceed recommended dosage

  • When using this product - Nighttime Severe Cold and Cough

    ▪
    do not exceed recommended dosage
    ▪
    avoid alcoholic drinks
    ▪
    marked drowsiness may occur
    ▪
    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 – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

    ▪
    nervousness, dizziness, or sleeplessness occurs
    ▪
    fever gets worse or lasts more than 3 days
    ▪
    redness or swelling is present
    ▪
    new symptoms occur
    ▪
    symptoms do not get better or worsen
    ▪
    pain, cough or nasal congestion gets worse or lasts more than 7 days
    ▪
    cough comes back or occurs with fever, 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions – Multi Symptom Severe Cold

    ▪
    do not use more than directed
    ▪
    take every 4 hours, while symptoms persist; Do not to take 6 packets in 24 hours or as directed by a doctor
     
    Age
     
    Dose
     
    Adults and children 12 years of age
     
    One packet
     
    Children under 12 years of age
     
    Do not use

    Directions Nighttime Severe Cold and Cough

    ▪
    do not use more than directed
    ▪
    take every 4 hours while symptoms persist;; not to exceed 5 packets in 24 hours or as directed by a doctor
     
    Age
     
    Dose
     
    Adults and children 12 years of age
     
    One packet
     
    Children under 12 years of age
     
    Do not use
    ▪
    Dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes
    ▪
    If using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
  • Other information - Multi Symptom Severe Cold

    ▪
    each packet contains: potassium 6 mg
    ▪
    store at controlled room temperature. Protect from excessive heat and moisture.
  • Other information - Nighttime Severe Cold and Cough

    ▪
    each packet contains: potassium 6 mg
    ▪
    store at room temperature. Protect from excessive heat and moisture.
  • Inactive ingredients - Multi Symptom Severe Cold

    anhydrous citric acid, caramel, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose

  • Inactive ingredients - Nighttime Severe Cold and Cough

    citric acid, FD&C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose.

  • Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL

    Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold* & Theraflu® Nighttime Severe Cold & Cough*

    Multi Symptom

    Severe Cold

    ACETAMINOPHEN - Pain reliever; Fever reducer

    DEXTROMETHORPHAN HBr – Cough suppressant

    PHENYLEPHRINE HCl – Nasal decongestant

    Relieves:

    •
    Nasal congestion
    •
    Sore throat pain
    •
    Cough
    •
    Headache
    •
    Body ache
    •
    Fever

    Green Tea & Honey Lemon Flavors

    6 PACKETS

    NIGHTTIME

    Severe Cold & Cough

    ACETAMINOPHEN - Pain reliever; Fever reducer

    DIPHENHYDRAMINE HCl – Antihistamine; Cough suppressant

    PHENYLEPHRINE HCl – Nasal decongestant

    Relieves:

    •
    Nasal congestion
    •
    Sore throat pain
    •
    Cough
    •
    Headache
    •
    Body ache
    •
    Fever
    •
    Runny nose
    •
    Sneezing

    Honey Lemon Flavor Infused with Chamomile &White Tea Flavors

    6 PACKETS

    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 are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold and Theraflu® Nighttime Severe Cold & Cough.

    CVS Health Multi symptom severe cold and cough relief
  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH 
    acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-768
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-768-121 in 1 CARTON; Type 0: Not a Combination Product09/21/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CARTON 6 
    Part 21 CARTON 6 
    Part 1 of 2
    CVS HEALTH MULTI SYMPTOM SEVERE COLD  MULTI SYMPTOM SEVERE COLD
    acetaminophen, dextromethorphan hbr, phenylephrine hcl 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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    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 finalpart34107/21/2015
    Part 2 of 2
    CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD  NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    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 finalpart34108/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/21/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
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