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Quality Choice day time severe cold and cough (Quality Home Products)

Available Formats

Dosage Form Package Information Links
GRANULE, FOR SOLUTION 6 GRANULE, FOR SOLUTION in 1 BOX (64525-0549-6) Label Information

Complete Quality Choice day time severe cold and cough Information

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)                        Purpose

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

    Dextromethorphan hydrobromide 20 mg ..............Cough suppresant

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


  • PURPOSE

    Uses

    -Temporarily relieves:

        -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

    -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.



  • ASK DOCTOR

    Ask a doctor before us 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.

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


  • DO NOT USE

    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

    -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

    In care 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 8 mg, sodium 20 mg

    -phenylketonurics: contains phenylalanine 14 mg per packet

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


  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE DAY TIME SEVERE COLD AND COUGH   BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS
    acetaminophen, dextromethorphan hbr, and phenylephrine hcl. granule, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64525-0549
    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) (Dextrose - UNII:IY9XDZ35W2) Dextromethorphan Hydrobromide 20 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    Acesulfame (UNII: MA3UYZ6K1H)  
    Aspartame (UNII: Z0H242BBR1)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color red (FD & C red No. 40) , blue (FD & C blue No.1) Score     
    Shape Size
    Flavor BERRY (Berry infused with menthol & Green tea flavors) , MENTHOL (menthol) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64525-0549-6 6 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/31/2009
    Labeler - Quality Home Products (205554157)