TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOCIATES LLC]

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TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOCIATES LLC]
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NDC 36800-859-26
Set ID 284d37fd-9604-4874-b99b-a119a4ba8c0f
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses

    •
    temporarily relieves:
    •
    sneezing
    •
    itchy nose or throat
    •
    runny nose
    •
    itchy, watery eyes due to hay fever
    •
    nasal and sinus congestion
    •
    cough due to minor throat and bronchial irritation as may occur with a cold
  • Warnings

    Do not use

    •
    in a child under 4 years of age
    •
    in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    •
    with any other product containing diphenhydramine, even one used on skin
    •
    to make a child sleepy

    Ask a doctor before use if the child has

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    glaucoma
    •
    cough that occurs with too much phlegm (mucus)
    •
    chronic cough that lasts or as occurs with asthma
    •
    a breathing problem such as chronic bronchitis

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product

    •
    do not exceed recommended dosage
    •
    may cause marked drowsiness
    •
    sedatives and tranquilizers may increase drowsiness
    •
    excitability may occur, especially in children

    Stop use and ask a doctor if

    •
    nervousness, dizziness or sleeplessness occurs
    •
    symptoms do not get better within 7 days or occur with fever
    •
    cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

    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).

  • Directions

    •
    may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
    •
    use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

    Age

    Dose

    children under

    4 years of age

    do not use

    children 4 to under

    6 years of age

    do not use unless

    directed by a doctor

    children 6 to under

    12 years of age

    10 mL
  • Other information

    •
    each 5 mL contains: sodium 3 mg
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    COMPARE TO CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH ACTIVE INGREDIENTS

    TRIACTING SYRUP

    children’s Night Time Cold & Cough

    ANTIHISTAMINE – COUGH SUPPRESSANT

    DIPHENHYDRAMINE HCl

    NASAL DECONGESTANT – PHENYLEPHRINE HCl

    Cough Relief

    Runny & Stuffy Nose

    Itchy Throat

    OUR PHARMACISTS RECOMMEND

    Ages 6 to under 12 Years

    GRAPE FLAVOR

    4 FL OZ (118 mL)

    childrens nighttime cold and cough image
  • INGREDIENTS AND APPEARANCE
    TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH 
    diphenhydramine hydrochloride, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-859
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-859-261 in 1 CARTON04/16/2019
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/16/2019
    Labeler - Topco Associates LLC (006935977)
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