Label: TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH- diphenhydramine hydrochloride, phenylephrine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 16, 2019

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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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