Label: WAL FLU SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride powder, for solution 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/10

If you are a consumer or patient please visit this version.

  • Active ingredient (in each packet)

    Acetaminophen 650 mg

    Dextromethorphan hydrobromide 20 mg

    Phenylephrine hydrochloride 10 mg

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  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

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  • Uses

    • temporarily relieves
    • minor aches and pains
    • minor sore throat
    • headache
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation
    • temporarily reduces fever
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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 packets in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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

    • 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 use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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 fever, 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not use more than directed – see Liver warning
    • take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
    • adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • children under 12 years of age: consult a doctor
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
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  • Other information

    • each packet contains: potassium 5 mg and sodium 41 mg
    • phenylketonurics: contains phenylalanine 17 mg per packet
    • store at 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Theraflu® Severe Cold & Cough active ingredients

    See New Warnings Information

    Daytime

    Wal-Flu®

    Severe Cold & Cough

    Pain Reliever–Fever Reducer (Acetaminophen)

    Cough Suppressant (Dextromethorphan HBr)

    Nasal Decongestant (Phenylephrine HCl)

    Nasal & Sinus Congestion

    Cough

    Body Ache

    Sore Throat Pain

    Headache

    Fever

    Berry Infused with Menthol & Green Tea Flavors

    Wal-Flu(R) Severe Cold and Cough Carton

    Wal-Flu(R) Severe Cold and Cough Carton

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  • 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 LABEL Item Code (Source) NDC:0363-0096
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ANHYDROUS CITRIC ACID  
    ASPARTAME  
    SILICON DIOXIDE  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    MALTODEXTRIN  
    SODIUM CITRATE  
    SUCROSE  
    TRIBASIC CALCIUM PHOSPHATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0096-91 6 in 1 CARTON
    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)
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