Label: THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup

  • NDC Code(s): 0067-8129-08
  • 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 17, 2020

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

  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer

    Antihistamine/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
    runny nose
    sneezing
    itchy nose or throat
    itchy, watery eyes due to hay fever
    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.
    with any other product containing diphenhydramine, even one used on the skin
    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
    glaucoma
    trouble urinating due to an enlarged prostate gland
    a breathing problem such as emphysema or chronic bronchitis
    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 sedatives or tranquilizers
    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dosage
    avoid alcoholic drinks
    marked drowsiness may occur
    alcohol, sedatives and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery
    excitability may occur, especially in children

    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 35 mg, sodium 17 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?

    1-800-452-0051

  • Principal Display Panel

    NDC 0067-8129-08

    THERAFLU

    ExpressMax

    NIGHTTIME

    SEVERE COLD & COUGH

    BERRY FLAVOR

    ACETAMINOPHEN

    PAIN RELIEVER/FEVER REDUCER

    DIPHENHYDRAMINE HCl

    ANTIHISTAMINE/COUGH SUPPRESSANT

    PHENYLEPHRINE HCl

    NASAL DECONGESTANT

    • COUGH • NASAL CONGESTION

    • SORE THORAT PAIN • FEVER

    • HEADACHE • BODY ACHE

    • RUNNY NOSE

    8.3 FL OZ (245.5mL)

    Alcohol Free

    * Maximum Strength per 4 hour dose.

    DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING

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

    ©2018 GSK group of companies or its licensor.

    13273

    13414_Theraflu ExpressMAX NT SCC_8.3 OZ.JPG
  • INGREDIENTS AND APPEARANCE
    THERAFLU EXPRESSMAX  NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
    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:0067-8129-08245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/15/2015
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)