Label: THERAFLU SEVERE COLD RELIEF COMBO PACK- acetaminophen, dextromethorphan hbr, diphenhydramine hcl kit

  • NDC Code(s): 0067-0100-06, 0067-0101-06, 0067-0123-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 1, 2024

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  • Active Ingredients (in each packet) (Daytime)

    Acetaminophen 500 mg

    Dextromethorphan HBr 20 mg

  • Purposes (Daytime)

    Pain reliever/Fever reducer

    Cough suppressant

  • Active ingredients (in each packet) (Nighttime)

    Acetaminophen 650 mg

    Diphenhydramine HCl 25 mg

  • Purposes (Nighttime)

    Pain reliever/Fever reducer

    Antihistamine/Cough suppressant

  • Uses (Daytime)

    • temporarily relieves these symptoms due to a cold:

     
    • minor aches and pains • minor sore throat pain • headache
     
    • cough due to minor throat and bronchial irritation

    • temporarily reduces fever

  • Uses (Nighttime)

    • temporarily relieves these symptoms due to a cold:

     
    • minor aches and pains • minor sore throat pain
     
    • headache • 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 (Daytime)

    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

    • 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

    Stop use and ask a doctor if

    • fever gets worse or lasts more than 3 days

    • redness or swelling is present

    • new symptoms occur

    • pain or cough 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.

  • Warnings (Nighttime)

    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 • 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

    • 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

    • fever gets worse or lasts more than 3 days • redness or swelling is present

    • new symptoms occur • cough comes back or occurs with rash or headache that lasts

    • pain or cough gets worse or lasts more than 7 days

    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 (Daytime)

    • 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. 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.

  • Directions (Nighttime)

    • 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 (Daytime)

    • each packet contains: potassium 10 mg, sodium 20 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.

  • Other information (Nighttime)

    • 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 (Daytime)

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

  • Inactive Ingredients (Nighttime)

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

  • Questions or comments? (Daytime)

    1-855-328-5259

  • Questions or comments? (Nighttime)

    1-855-328-5259

  • Other Information

    DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
    SEVERE COLD RELIEF 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

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

    DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
    SEVERE COLD RELIEF 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 SEVERE COLD RELIEF NIGHTTIME PRODUCT
    SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF
    DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

    TAMPER EVIDENT INNER UNIT
    DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

    1-855-328-5259

    Distributed by: Haleon, Warren, NJ 07059
    ©2023 Haleon group of companies or its licensor.
    Trademarks are owned by or licensed to the Haleon group of companies.
    Pat. Info www.productpats.com

    207735

  • Package/Label Principal Display Panel

    MULTI-SYMPTOM COLD RELIEF

    NEW FORMULA

    THERAFLU

    SEVERE

    COLD RELIEF

    MULTI-SYMPTOM COLD RELIEF

    Hot liquid therapy that relieves:

    /Cough /Sore throat pain /Head and body ache

    /Fever /Runny nose (Nighttime only)

    /Sneezing (Nighttime only)

    Honey Lemon Flavor

    USE AS DIRECTED

    DAYTIME

    Acetaminophen Pain Reliever/Fever Reducer

    Dextromethorphan HBr Cough suppressant

    NIGHTTIME

    Acetaminophen Pain Reliever/Fever Reducer

    Diphenhydramine HCl Antihistamine/Cough Suppressant

    DAYTIME

    18 PACKETS

    24 TOTAL PACKETS

    NIGHTTIME

    6 PACKETS

    Theraflu SCR Combo Pack 24 Ct
  • INGREDIENTS AND APPEARANCE
    THERAFLU  SEVERE COLD RELIEF COMBO PACK
    acetaminophen, dextromethorphan hbr, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0123
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0123-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product06/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PACKET 3 
    Part 21 PACKET 1 
    Part 1 of 2
    THERAFLU SEVERE COLD RELIEF DAYTIME 
    acetaminophen, dextromethorphan hbr powder, for solution
    Product Information
    Item Code (Source)NDC:0067-0100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorWHITE ((to off white, yellow, and brown)) Score    
    ShapeSize
    FlavorHONEY (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0100-066 in 1 CARTON
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Part 2 of 2
    THERAFLU SEVERE COLD RELIEF NIGHTTIME 
    acetaminophen, diphenhydramine hcl powder, for solution
    Product Information
    Item Code (Source)NDC:0067-0101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorWHITE ((to off white, yellow, and brown)) Score    
    ShapeSize
    FlavorHONEY (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0101-066 in 1 CARTON
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2024
    Labeler - Haleon US Holdings LLC (079944263)
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