Label: THERAFLU POWERPODS DAYTIME SEVERE COLD- acetaminophen, dextromethorphan, phenylephrine powder, for solution

  • NDC Code(s): 0067-6094-01, 0067-6094-02, 0067-6094-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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

  • Active ingredients (in each pod)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/Fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves these symptoms due to a cold:
    o
    minor aches and pains
    o
    minor sore throat pain
    o
    headache
    o
    nasal and sinus congestion
    o
    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

    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

    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 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 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
    pain, cough or nasal congestion gets worse or lasts more than 7 days
    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. 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, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor.

    Age

    Dose

    adults and children 12 years of age and over

    one pod

    children under 12 years of age

    do not use

    do not remove the foil seal as the pod will not work properly and could result in hot water burns
    place pod in compatible brewer
    use a minimum of 8 oz. of water
    when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping.
    remove used pod and flush brewer after use with a minimum of 8 oz. of water
    sip while hot. Consume entire drink within 10-15 minutes.
  • Other information

    each pod contains: potassium 10 mg, sodium 20 mg
    phenylketonurics: contains phenylalanine 14 mg per pod
    do not open pouch until time of use
    store at controlled room temperature 20o-25oC (68o-77oF). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

  • Questions or comments?

    call 1-855-328-5259

  • Principal Display

    NDC 0067-6094-01

    NEW

    THERAFLU

    POWERPODS

    DAYTIME

    SEVERE COLD

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

    Nasal Congestion
    Sore Throat Pain
    Cough
    Headache
    Body Ache
    Fever

    BERRY INFUSED WITH MENTHOL & GREEN TEA FLAVORS

    8 PODS

    FOR USE ONLY WITH COMPATIBLE SINGLE SERVE BREWING MACHINES INCLUDING KEURIG AND MR. COFFEE*

    *This product is not affiliated with Keurig Incorporated or Mr. Coffee.

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

    KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

    TAMPER EVIDENT POUCH. PRODUCT IS PACKAGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF POUCH IS TORN OR BROKEN. DO NOT OPEN POUCH UNTIL TIME OF USE.

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    PRESS

    Press the 8 oz. setting on your machine to brew.

    SIP

    Sip while hot. Consume entire drink within 10-15 minutes. Remove used pod and flush brewer after use

    with a minimum of 8 oz. of water.

    CAUTION: PRODUCT LIQUID AND POD WILL BE HOT.

    RELIEF

    Prepare to experience powerful cold & flu multi-symptom relief.

    1-855-328-5259

    Distributed by:

    GSK Consumer Healthcare, Warren, NJ 07059

    ©2018 GSK group of companies or its licensor.

    Trademarks are owned by or licensed to the GSK group of companies.

    13019

    13019_Theraflu PowerPods Daytime Severe Cold_8 pods.JPG
  • INGREDIENTS AND APPEARANCE
    THERAFLU  POWERPODS DAYTIME SEVERE COLD
    acetaminophen, dextromethorphan, phenylephrine powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6094
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6094-018 in 1 CARTON07/28/2018
    1NDC:0067-6094-021 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0067-6094-031 in 1 CARTON01/20/2019
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/28/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)