Label: THERAFLU COUGH RELIEF- dextromethorphan hbr, guaifenesin powder, for solution

  • NDC Code(s): 0067-6089-01, 0067-6089-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 December 15, 2020

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  • Active ingredients (in each packet)

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    •
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    Do not use

    •
    in a child under 12 years of age
    •
    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

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    •
    a sodium-restricted diet

    When using this product

    •
    do not exceed recommended dosage

    Stop use and ask a doctor if

    •
    cough lasts more than 7 days, 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    do not use more than directed
    •
    take every 4 hours. Do not take more than 6 packets in 24 hours.

    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 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 39 mg
    •
    phenylketonurics: contains phenylalanine 24 mg per packet
    •
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FDC blue no. 1, FDC red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

  • Questions or comments?

    call 1-855-328-5259

  • Principal Display Panel

    NDC 0067-6089-01

    NEW

    THERAFLU

    COUGH RELIEF

    DEXTROMETHORPHAN HBr

     
    COUGH SUPPRESSANT

    GUAIFENESIN

     
    EXPECTORANT
    1.
    Controls Cough
    2.
    Loosens Chest Congestion
     
    HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS
     
    6 PACKETS
     
    PARENTS:
     
    Learn about teen medicine abuse
     
    www.StopMedicineAbuse.org
     
    TAMPER EVIDENT INNER UNIT
     
    DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
     
    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
     
    1-855-328-5259
     
    Distributed by:
     
    GSK Consumer Healthcare, Warren, NJ 07059
     
    © 2018 GSK group of companies or its licensor.
     
    Trademarks are owned or licensed to the GSK group of companies.
     
    62000000027600
    6200000002760_Theraflu Cough Relief_6 packets.JPG
  • INGREDIENTS AND APPEARANCE
    THERAFLU  COUGH RELIEF
    dextromethorphan hbr, guaifenesin powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    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:0067-6089-016 in 1 CARTON07/01/2019
    1NDC:0067-6089-031 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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