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THERAFLU (Novartis Consumer Health, Inc.)

Available Formats

Dosage Form Package Information Links
POWDER, FOR SOLUTION 6 POWDER, FOR SOLUTION in 1 CARTON (0067-6426-06) Label Information

Complete THERAFLU Information

  • Theraflu Multi-Symptom Severe Cold


  • Active ingredients (in each packet)

    Acetaminophen 500 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
    • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.
     
    Age
     
    Dose
     
    • adults and children 12 years of age and over
     
    • one packet
     
    • children under 12 years of age
     
    • do not use
    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

  • Other information

    each packet contains: potassium 10 mg, sodium 19 mg
    phenylketonurics: contains phenylalanine 20 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no.1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate


  • Questions or comments?

    call 1-855-328-5259


  • Theraflu Nighttime Severe Cold & Cough


  • Active Ingredients (in each packet)

    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
    • headache
    • runny nose
    • itchy nose or throat
    • cough due to minor throat and bronchial irritation
    • minor sore throat pain
    • nasal and sinus congestion
    • sneezing
    • itchy watery eyes due to hay fever
    • 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
    • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
     
    Age
     
    Dose
     
    • adults and children 12 years of age and over
     
    • one packet
     
    • children under 12 years of age
     
    • do not use
    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

  • Other information

    each packet contains: potassium 10 mg, sodium 23 mg
    phenylketonurics: contains phenylalanine 13 mg per packet
    • store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

  • Inactive Ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no.1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate


  • Questions or comments?

    Call 1-855-328-5259


  • Principal Display Panel

    THERAFLU

    MULTI-SYMPTOM SEVERE COLD

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

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

    TEA INFUSIONS

    GREEN TEA & HONEY LEMON FLAVORS

    6 MULTI-SYMPTOM PACKETS

    NIGHTTIME SEVERE COLD & COUGH

    ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

    DIPHENHYDRAMINE HCl - ANTIHISTAMINE/COUGH SUPRESSSANT

    PHENYLEPHRINE HCl – NASAL DECONGESTANT

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

    Honey Lemon, Chamomile & White Tea Flavors

    6 NIGHTTIME PACKETS

    12 TOTAL PACKETS

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

    DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT 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 MULTI-SYMPTOM PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

    DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

    PARENTS: Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    TAMPER-EVIDENT INNER UNIT.

    DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

    1-855-328-5259

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2017 GSK group of companies or its licensor.

    13215

    13215_Theraflu MS SC & Theraflu NT SCC combo_12 ct.JPG

  • INGREDIENTS AND APPEARANCE
    THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-7919
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-7919-12 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 01/01/2016
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 CARTON
    Part 2 1 CARTON
    Part 1 of 2
    THERAFLU  MULTI SYMPTOM SEVERE COLD
    acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
    Product Information
    Item Code (Source) NDC:0067-6426
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor HONEY (Green Tea & Honey Lemon Flavors) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6426-06 6 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2014
    Part 2 of 2
    THERAFLU  NIGHTTIME SEVERE COLD AND COUGH
    acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
    Product Information
    Item Code (Source) NDC:0067-7918
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor HONEY, LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-7918-06 6 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)