THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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  • THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0067-8137-10, 0067-8137-20
Set ID 62f7fcb9-e31a-4634-b1c2-44a9567e3a61
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 ingredient

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine/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
    runny nose
    o
    sneezing
    o
    itchy nose or throat
    o
    itchy, watery eyes due to hay fever
    o
    cough due to minor throat and bronchial irriation
    •
    temporarily reduces fever
  • Warnings

    Liver warning: This product ocontains acetaminophen. Severe lever 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 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 operation 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
    •
    adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    Benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide

  • Questions or Comments?

    call 1-800-452-0051

  • Principal Display Panel

    NDC 0067-8137-20

    Theraflu® Express Max™

    NIGHTTIME

    SEVERE COLD & COUGH

    NEW!

    WARMING RELIEF™ FORMULA

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

    PEHNYLEPHRINE HCl – NASAL DECONGESTANT

    •
    NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE
    •
    RUNNY NOSE • HEADACHE • COUGH

    20 COATED CAPLETS

    *Maximum Strength per 4 hour dose.

    TAMPER EVIDENT FEATURE:

    THERAFLU® EXPRESSMAX™ CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2016 GSK group of companies or its licensor. All rights reserved.

    www.theraflu.com

    46171251

    Theraflu Expressmax Nighttime Severe Cold and Cough caplet carton
  • INGREDIENTS AND APPEARANCE
    THERAFLU EXPRESSMAX  NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVAL (caplet) Size18mm
    FlavorMINTImprint Code 1143N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8137-202 in 1 CARTON07/05/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-8137-101 in 1 CARTON06/08/2017
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/05/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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