Label: FAMILY DOLLAR NIGHTTIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS- acetaminophen, diphenhydramine hcl and phenylephrine hcl granule, for solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 19, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (in each packet) Purpose

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

    Diphenhydramine hydrochloride 25 mg .........Anitihistamine/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

    - runny nose - sneezing - itchy, watery eyes due to hay fever

    - itchy nose and throat

    - 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 redenning - 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

    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). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    - with any other product containing diphenhydramine, even one used on the skin

    - If you are now taking a prescription monoamine oxidase (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 - glaucoma - diabetes - 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.

    - a sodium restricted diet.

  • 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.

    AgeDose
    children under 4 years of age do 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 10 mg, sodium 47 mg



    - phenylketonurics: each packet contains phenylalanine 13 mg



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

  • INACTIVE INGREDIENT

    Acesulfame potassium, anhydrous citric acid, Aspartame, Caramel Color, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.

  • PRINCIPAL DISPLAY PANEL

    Family Wellness Nighttime

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR NIGHTTIME SEVERE COLD AND COUGH  HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS
    acetaminophen, diphenhydramine hcl and phenylephrine hcl granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-0566
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    ACESULFAME (UNII: MA3UYZ6K1H)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    Coloryellow (Caramel Color) , yellow (D & C Yellow 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:64525-0566-66 in 1 BOX; Type 0: Not a Combination Product11/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/24/2015
    Labeler - Quality Home Products (205554157)