Label: THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST- acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride powder

  • NDC Code(s): 0067-6800-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 27, 2024

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  • Active ingredients (in each packet)

    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 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
    •
    pain, cough or nasal congestion gets worse or last 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 packets in 24 hours unless directed by a doctor.
     
    Age
     
    Dose
     
    adults and children
     
    12 years of age and over
     
    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

    •
    each packet contains: potassium 10 mg, sodium 20 mg
    •
    phenylketonurics: contains phenylalanine 14 mg per packet
    •
    store at controlled room temperature 20 - 25°C (68 - 77°F). 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, soy lecithin, sucrose, tribasic calcium phosphate

  • Questions or Comments?

    call 1-855-328-5259

  • Additional Information

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

    KEEP CARTON FOR REFERENCE. DO NOT DISCARD

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.com

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

    1-855-328-5259

    Distributed by: GSK Consumer Healthcare
    Warren, NJ 07059
    ©2022 GSK group of companies or its licensor.
    Trademarks are owned by or licensed to the GSK group of companies.

    PA_620000000201493

    HOT LIQUID THERAPY
    that relieves:

    Nasal and sinus congestion

    Cough

    Sore throat pain

    Headache

    Fever

    CARTON
    RECYCLE

  • Principal Display Panel

    HALEON

    NDC 0067-6800-02

    MULTI-SYMPTOM COLD RELIEF

    THERAFLU

    SEVERE

    COLD RELIEF

    DAYTIME FORMULA

    ACETAMINOPHEN
    Paint Reliever/Fever Reducer

    Dextromethorphan HBr
    Cough Suppressant

    PHENYLEPHRINE HCl
    Nasal Decongestant

    Hot liquid therapy
    that relieves:

    / Nasal and sinus congestion
    / Cough
    / Sore throat pain
    / Headache
    / Fever

    Berry Burst Flavor

    6 PACKETS

    Y:\HAL-CH Drug Listing\CH WORKING\Theraflu Berry Burst 0067-6800\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG
  • INGREDIENTS AND APPEARANCE
    THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST 
    acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6800
    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)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorPINK (Pink-purple) Score    
    ShapeSize
    FlavorBERRY (Burst) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6800-026 in 1 CARTON; Type 0: Not a Combination Product01/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/20/2022
    Labeler - Haleon US Holdings LLC (079944263)
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