WAL FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [WALGREEN COMPANY]

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  • WAL FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [WALGREEN COMPANY]

WAL FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [WALGREEN COMPANY]
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NDC 0363-0964-91, 0363-1319-55, 0363-8319-91
Set ID 39189dd1-14df-4091-a47b-d45cc4d5f9c0
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each packet) - Daytime

    Acetaminophen 500 mg

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

  • Purpose

    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 have ever had an allergic reaction to this product or any of its ingredients
    •
    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
    •
    a sodium-restricted diet

    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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 (see overdose warning)
    •
    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.
  • Other information

    •
    each packet contains: potassium 10 mg and sodium 25 mg
    •
    phenylketonurics: contains phenylalanine 22 mg per packet
    •
    store at 20-25°C (68-77°F). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

  • Questions or comments?

    1-800-719-9260

  • Active ingredients (in each packet) - Nighttime

    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 have ever had an allergic reaction to this product or any of its ingredients
    •
    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 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 (see overdose warning)
    •
    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 and sodium 25 mg
    •
    phenylketonurics: contains phenylalanine 13 mg per packet
    •
    store at 20-25°C (68-77°F). Protect product from heat and moisture.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    DAY & NIGHT PACK

    MULTI-SYMPTOM

    Wal-Flu®

    Severe

    COLD

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    Relieves nasal congestion, sore throat pain, cough, headache, body ache & fever

    GREEN TEA & HONEY LEMON FLAVORS

    6 PACKETS

    Compare to Theraflu® Multi-Symptom Severe Cold & Theraflu® Nighttime Severe Cold & Cough active ingredients

    NIGHTTIME

    Wal-Flu®

    Severe

    COLD & COUGH

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER

    DIPHENHYDRAMINE HCl/ ANTIHISTAMINE / COUGH SUPPRESSANT

    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    Relieves nasal congestion, cough, body ache, sore throat pain, runny nose, sneezing, headache & fever

    HONEY LEMON INFUSED WITH WHITE TEA FLAVORS

    6 PACKETS

    TOTAL 12 PACKETS

    Wal-Flu Severe Carton Image 1
    Wal-Flu Severe Carton Image 2
  • INGREDIENTS AND APPEARANCE
    WAL FLU SEVERE 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1319
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1319-551 in 1 CARTON; Type 0: Not a Combination Product09/19/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CARTON 6 
    Part 21 CARTON 6 
    Part 1 of 2
    WAL FLU SEVERE COLD 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
    Product Information
    Item Code (Source)NDC:0363-8319
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (green tea) , LEMON (green tea) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8319-916 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/16/2018
    Part 2 of 2
    WAL FLU SEVERE COLD AND COUGH 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
    Product Information
    Item Code (Source)NDC:0363-0964
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorWHITE (mixture of white, light yellow-orange particles) , ORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0964-916 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/19/2018
    Labeler - Walgreen Company (008965063)
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