WALGREENS SUGAR FREE NIGHTTIME WAL-FLU SEVERE COLD AND COUGH NATURAL HONEY LEMON FLAVOR (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [WALGREEN CO.]

WALGREENS SUGAR FREE NIGHTTIME WAL-FLU SEVERE COLD AND COUGH NATURAL HONEY LEMON FLAVOR (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, AND PHENYLEPHRINE HCL.) GRANULE, FOR SOLUTION [WALGREEN CO.]
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NDC 0363-0602-06
Set ID 3568f379-3743-4a83-b7b1-887c19d24020
Category HUMAN OTC DRUG LABEL
Packager Walgreen Co.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each packet) Purpose

    Acetaminophen 650 mg .......................................Pain reliever/Fever reducer

    Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant

    Phenylephrine hydrochloride 10 mg .................................Nasal decongestant.

  • PURPOSE

    Uses

    - temporarily relieves:

    - minor aches and pains - minor sore throat pain

    - headache - nasal and sinus congestion

    - runny nose - sneezing

    - itchy nose and throat - itchy, watery eyes due to hay fever

    - cough due to minor throat and bronchial irritation

    - temporarily reduces fever.

  • WARNINGS

    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 - 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

    Do not use

    - In a child under 4 years of age.

    - With any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

    - 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 a MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

    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, asthma, 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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    - taking sedatives or tranquilizers

    - taking the blood thinning drug warfarin.

  • INDICATIONS & USAGE

    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

    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 - symptoms do not get better or worsen

    - 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    - do not use more than directed

    - take every 4 hours; not to 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 into 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.

  • INFORMATION FOR PATIENTS

    Other information

    - each packet contains: potassium 10 mg,

    sodium 19 mg

    - phenylketonurics: contains phenylalanine

    11 mg per packet

    - store at controlled room temperature

    20-25C (68-77F). Protect from

    excessive heat and moisture.

  • INACTIVE INGREDIENT

    Acesulfame K, aspartame, calcium phosphate dibasic, citric acid, D and C Yellow 10, maltodextrin, natural flavor, silicon dioxide, sodium citrate dihydrate.

  • PRINCIPAL DISPLAY PANEL

    MM1.jpg

  • INGREDIENTS AND APPEARANCE
    WALGREENS SUGAR FREE NIGHTTIME WAL-FLU SEVERE COLD AND COUGH  NATURAL HONEY LEMON FLAVOR
    acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0602
    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 (UNII: MA3UYZ6K1H)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Coloryellow (D & C Yellow 10) Score    
    ShapeSize
    FlavorHONEY (Natural Honey & Lemon Flavor) , LEMON (Natural Honey & Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0602-066 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/15/2014
    Labeler - Walgreen Co. (008965063)