CVS HEALTH MULTI SYMPTOM SEVERE COLD MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [CVS PHARMACY,INC.]

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  • CVS HEALTH MULTI SYMPTOM SEVERE COLD MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [CVS PHARMACY,INC.]

CVS HEALTH MULTI SYMPTOM SEVERE COLD MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [CVS PHARMACY,INC.]
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NDC 59779-877-06
Set ID 1dad0528-e99f-45b8-a072-3c6249bf2bcd
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy,Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each packet)

    Acetaminophen 500 mg

    Dextromethorphan hydrobromide 20 mg

    Phenylephrine hydrochloride 10 mg

  • Purposes

    Pain reliever / fever reducer

    Cough Suppressant

    Nasal Decongestant

  • Uses

    •
    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
  • Warnings

    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

    •
    in a child under 4 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 a 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)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    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

    •
    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 care 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not use more than directed
    •
    take every 4 hours ; not to exceed 6 packets in 24 hours or as directed by a doctor

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 12 years of age

    do not use unless directed by a doctor

    adults and children 12 years of age and over

    one packet
    •
    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

    •
    each packet contains: potassium 6 mg
    •
    store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.
  • Inactive ingredients

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

    Questions or Comments

    1-866-467-2748

  • Principal Display

    CVS Health Multi-Symptom Severe Cold 6 Packets

    CVS Health™

    Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*

    Severe

    NDC 59779-877-06

    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

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,

    Multi-Symptom Severe Cold

    CVS Health™ Multi-Symptom Severe Cold provides complete relief of your severe cold symptoms. This soothing hot liquid formula is dye free, aspartame free and sodium free and tastes great.

    For nighttime relief, try CVS Health™ Nighttime Severe Cough & Cold.

    TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

    Dye, Aspartame, & Sodium free

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2015 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-12431

    CVS® Quality

    Money back Guarantee

    *This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Multi-Symptom Severe Cold

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MULTI SYMPTOM SEVERE COLD  MULTI SYMPTOM SEVERE COLD
    acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-877
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (Green Tea infused with Honey Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-877-066 in 1 CARTON; Type 0: Not a Combination Product07/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/21/2015
    Labeler - CVS Pharmacy,Inc. (062312574)
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