Label: THERAFLU SEVERE COLD RELIEF DAYTIME WITH HONEY GINGER FLAVOR- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution

  • NDC Code(s): 0067-8211-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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

  • 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:
      • 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

    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 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.
  • 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 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 5 mg, sodium 21 mg
    • phenylketonurics:contains phenylalanine 14 mg per packet
    • store at controlled room temperature 20 -25 oC (68-77 oF). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, aspartame, citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, honey solids, maltodextrin, medium chain triglycerides, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, triacetin, tribasic calcium phosphate

  • Questions or comments?

    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.org

    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.

  • Principal Display Panel

    THERAFLU

    NEW FLAVOR

    MULTI-SYMPTOM COLD RELIEF

    SEVERECOLD RELIEF

    Acetaminophen
    Pain Reliever/Fever Reducer

    Dextromethorphan HBr
    Cough Suppressant

    Phenylephrine HCl
    Nasal Decongestant

    DAYTIME FORMULA

    Hot liquid therapy
    that relieves:

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

    Honey Ginger

    6 PACKETS

    PA 62000000200567 – Carton Front

    Theraflu Severe CR Daytime 6 ct carton
  • INGREDIENTS AND APPEARANCE
    THERAFLU   SEVERE COLD RELIEF DAYTIME WITH HONEY GINGER FLAVOR
    acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8211
    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)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HONEY (UNII: Y9H1V576FH)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Colorwhite (off-white, beige, brown) Score    
    ShapeSize
    FlavorHONEY (Ginger) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8211-016 in 1 CARTON05/01/2023
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2023
    Labeler - Haleon US Holdings LLC (079944263)