WINCO FOODS MULTI-SYMPTOM SEVERE COLD GREEN TEA AND HONEY LEMON FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [WINCO FOODS, LLC]

WINCO FOODS MULTI-SYMPTOM SEVERE COLD GREEN TEA AND HONEY LEMON FLAVORS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [WINCO FOODS, LLC]
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NDC 67091-291-06
Set ID 34a0e427-a63a-5664-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Winco Foods, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Multi-Symptom Severe Cold with Green Tea and Honey Lemon flavors

    Active ingredients (in each packet) Purpose

    Acetaminophen 500 mg ........................................Pain reliever/Fever reducer
    Dextromethorphan hydrobromide 20 mg ..............Cough suppressant
    Phenylephrine hydrochloride 10 mg.......................Nasal decongestant.

  • PURPOSE

    Uses

    - Temporarily relieves these symptoms due to a cold:

    - minor aches and pains - headache - minor sore throat pain

    - nasal and sinus congestion - 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.

    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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

  • DO NOT USE

    Do not use

    - In a child under 4 years of age.

    - If you are allergic to acetaminophen.

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

    - 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 - 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.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

  • INDICATIONS & USAGE

    When using this product

    - do not exceed recommended dosage.

  • 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

    - do not use more than directed

    - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.

    AgeDose
    children under 4 years of agedo not use
    children 4 to under 12 years of agedo not use unless directed by a doctor
    adults and children 12 years of age and overone 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.

  • INFORMATION FOR PATIENTS

    Other information

    - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg.
    - phenylketonurics: contains phenylalanine 13 mg per packet

    - store at controlled room temperature 20-25C (68-77F). Protect from heat and moisture.

  • INACTIVE INGREDIENT

    Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, silicon dioxide, Sodium Citrate, Starch, Sucrose.

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS MULTI-SYMPTOM SEVERE COLD  GREEN TEA AND HONEY LEMON FLAVORS
    acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-291
    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)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Coloryellow (Caramel color) , yellow (D and C Yellow No. 10) Score    
    ShapeSize
    FlavorHONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-291-066 in 1 BOX; Type 0: Not a Combination Product06/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/06/2016
    Labeler - Winco Foods, LLC (056098817)

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