Label: THERAFLU EXPRESSMAX SEVERE COLD AND FLU CAPLETS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated

  • NDC Code(s): 0067-8145-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.
  • Category: HUMAN OTC DRUG LABEL

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 June 1, 2017

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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 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, chromic 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
    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

    each caplet contains: sodium 5 mg
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    benzoic acid, carmine, croscarmellose sodium, crospovidone, ethanol, ferric oxide yellow, flavors, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide

  • Questions or Comments?

    call 1-855-328-5259

  • Package/Label Principal Display Panel

    NDC 0067-8145-01

    Theraflu®Expressmax

    SEVERE COLD AND FLU

    NEW!

    WARMING RELIEF FORMULA

    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
    20
    COATED CAPLETS
     
    PARENTS:
     
    Learn about teen medicine abuse
     
    www.StopMedicineAbuse.org
     
    *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.
     
    Read all warnings and directions on carton before use. Keep carton for reference. Do not discard.
     
    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.
     
    12982_Theraflu expressmax cold and flu caps_20ct.jpg
  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    THERAFLU EXPRESSMAX SEVERE COLD AND FLU CAPLETS 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    ALCOHOL (UNII: 3K9958V90M)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    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
    ColorREDScoreno score
    ShapeOVAL (Capsule shaped) Size19mm
    FlavorMINTImprint Code IL5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8145-012 in 1 CARTON07/17/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/17/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
    Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mallinckrodt, Inc.097722284API MANUFACTURE(0067-8145)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVI's Laboratories Limited918598199API MANUFACTURE(0067-8145)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918457644API MANUFACTURE(0067-8145)