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wal flu severe cold and cough (Walgreen Company)

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POWDER, FOR SOLUTION 6 POWDER, FOR SOLUTION in 1 CARTON (0363-0096-91) Label Information

Complete wal flu severe cold and cough Information

  • Active ingredient (in each packet)

    Acetaminophen 650 mg

    Dextromethorphan hydrobromide 20 mg

    Phenylephrine hydrochloride 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
    • 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 5 packets in 24 hours unless directed by a doctor.

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 12 years of age

    do not use unless directed by a doctor

    adults and children 12 years of age and over

    one packet

    • 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 5 mg and sodium 43 mg
    • phenylketonurics: contains phenylalanine 17 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, FD&C blue #1, FD&C red #40, flavor, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate


  • Questions or comments?

    1-800-719-9260


  • Package/Label Principal Display Panel

    DAYTIME

    Wal-Flu® Severe Cold & Cough

    Acetaminophen / Pain Reliever / Fever Reducer

    Dextromethorphan HBr / Cough Suppressant

    Phenylephrine HCl / Nasal Decongestant

    Relieves:

    Nasal & sinus congestion

    Cough

    Body ache

    Sore throat pain

    Headache

    Fever

    BERRY Infused With Menthol Flavor

    Compare to Theraflu® Daytime Severe Cold & Cough active ingredients

    6 PACKETS

    SEE NEW WARNINGS

    Walgreens Wal-Flu Severe Cold & Cough Image 1
    Walgreens Wal-Flu Severe Cold & Cough Image 2

  • INGREDIENTS AND APPEARANCE
    WAL FLU SEVERE COLD AND COUGH  DAYTIME
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0096
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0096-91 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 01/17/2012
    Labeler - Walgreen Company (008965063)