THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC.]

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  • THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC.]

THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC.]
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NDC 0067-8132-08
Set ID 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    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
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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, chronic bronchitis 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
    •
    measure the dose correctly using the enclosed dosing cup
    •
    take every 4 hours in dosing cup provided, while symptoms persist
    •
    do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
     
    Age
     
    Dose
     
    adults and children 12 years of age and over
     
    30 mL
     
    children under 12 years of age
     
    do not use
  • Other information

    •
    each 30 mL contains: potassium 30 mg, sodium 14 mg
    •
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or Comments?

    call 1-855-328-5259

  • Package/Label Principal Display Panel

    NDC 0067-8132-08

    Theraflu®Expressmax™

    SEVERE COLD AND FLU

    ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

    DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

    GUAIFENESIN- EXPECTORANT

    PHENYLEPHRINE HCl- NASAL DECONGESTANT

    •
    BODY ACHE
    •
    FEVER
    •
    CHEST CONGESTION
    •
    NASAL CONGESTION
    •
    HEADACHE
    •
    COUGH
    •
    SORE THROAT PAIN

    ALCOHOL FREE

    BERRY FLAVOR 8.3 FL OZ (245.5 mL)

     
    PARENTS:
     
    Learn about teen medicine abuse
     
    www.StopMedicineAbuse.org
     
    *Maximum Strength per 4 hour dose.
     
    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
     
    Trademarks are owned or licensed to the GSK group of companies.
     
    © 2016 GSK group of companies or its licensor. All rights reserved.
     
    12265_Theraflu expressmax severe cold and flu syrup.jpg
  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8132
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8132-081 in 1 BOTTLE; Type 0: Not a Combination Product07/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
    Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mallinckrodt, Inc.097722284API MANUFACTURE(0067-8132)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVI's Laboratories Limited918598199API MANUFACTURE(0067-8132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918457644API MANUFACTURE(0067-8132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Iwaki Seiyaku Co. Ltd711708664API MANUFACTURE(0067-8132)
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