Label: THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK- acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, diphenhydramine hcl, phenylephrine hcl kit

  • NDC Code(s): 0067-8125-16, 0067-8127-08, 0067-8129-08
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 10, 2024

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  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer

    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
      • 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.
    • 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 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
    1. Age
    1. Dose
    1. adults and children 12 years of age and over
    1. 30 mL
    1. children under 12 years of age
    1. 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?

    call 1-800-328-5259

  • Theraflu ExpressMax Nighttime Severe Cold & Cough

  • Drug Facts

  • 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 a MAO, 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
    1. Age
    1. Dose
    1. adults and children 12 years of age and over
    1. 30 mL
    1. children under 12 years of age
    1. 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?

    call 1-800-328-5259

  • Other Safety Information

    DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

    DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

    PARENTS:Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING

    Distributed by: GSK Consumer Healthcare

    Warren, NJ 07059

    ©2019 GSK group of companies or its licensor.

    13440

  • Principal Display Panel

    NDC 0067-8125-16

    THERAFLU

    ExpressMax

    DAYTIME

    SEVERE COLD & COUGH

    BERRY FLAVOR

    ACETAMINOPHEN

    PAIN RELIEVER/FEVER REDUCER

    DEXTROMETHORPHAN HBr

    COUGH SUPPRESSANT

    PHENYLEPHRINE HCl

    NASAL DECONGESTANT

    • Cough • Nasal Congestion

    • Sore Throat Pain • Fever

    • Headache • Body Ache

    8.3 FL OZ (245.5mL)

    Alcohol Free

    DAYTIME

    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 Throat Pain • Fever

    • Headache • Body Ache

    • Runny Nose

    8.3 FL OZ (245.5mL)

    Alcohol Free

    NIGHTTIME

    • 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)Use Only As Directed
    13440_Theraflu DT-NT Severe Cold & Cough Combo pack_2 bottles of 8.3 OZ.JPG
  • Principal Display Panel

    NDC 0067-8127-08

    THERAFLU

    ExpressMax

    DAYTIME

    SEVERE COLD & COUGH

    BERRY FLAVOR

    ACETAMINOPHEN

    PAIN RELIEVER/FEVER REDUCER

    DEXTROMETHORPHAN HBr

    COUGH SUPPRESSANT

    PHENYLEPHRINE HCl

    NASAL DECONGESTANT

    • Cough • Nasal Congestion

    • Sore Throat Pain • Fever

    • Headache • Body Ache

    8.3 FL OZ (245.5mL)

    Alcohol Free

    Theraflu ExpressMAX DT SCC.jpg
  • 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 Throat Pain • Fever

    • Headache • Body Ache

    • Runny Nose

    8.3 FL OZ (245.5mL)

    Alcohol Free

    13414_Theraflu ExpressMAX NT SCC_8.3 OZ.JPG.jpg
  • INGREDIENTS AND APPEARANCE
    THERAFLU EXPRESSMAX   DAYTIME NIGHTTIME VALUE PACK
    acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8125
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8125-161 in 1 CARTON; Type 0: Not a Combination Product07/15/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 245.5 mL
    Part 21 BOTTLE 245.5 mL
    Part 1 of 2
    THERAFLU EXPRESSMAX   DAYTIME SEVERE COLD AND COUGH
    acetaminophen, dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Item Code (Source)NDC:0067-8127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 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:0067-8127-08245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2015
    Part 2 of 2
    THERAFLU EXPRESSMAX   NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl syrup
    Product Information
    Item 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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2015
    Labeler - Haleon US Holdings LLC (079944263)
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