Label: NIGHTTIME COLD AND COUGH CHILDRENS- diphenhydramine hcl, phenylephrine hcl liquid

  • NDC Code(s): 63941-984-04
  • Packager: Best Choice (Valu Merchandisers Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 20, 2024

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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
      • runny nose
      • itchy nose or throat
      • itchy, watery eyes due to hay fever
      • nasal and sinus congestion
      • cough due to minor throat and bronchial irritations 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
    • for the purpose of making your 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
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not give more than 6 doses in 24 hours unless directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL= milliliter
    • shake well before using
    AgeDose 
    children 6 to under 12 years of age 10 mL every 4 hours
    children 4 to under 6 years of agedo not use unless directed by a doctor
    children under 4 years do not use 

  • Other Information

    • each 5 mL contains: sodium 3 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
    • protect from light
  • Inactive ingredients

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

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough

    Children's Triacting Night Time Cold & Cough

    Diphenhydramine HCl 6.25 mg

    Antihistamine / Cough Suppressant

    Phenylephrine HCl 2.5 mg

    Nasal Decongestant

    Multi-symptom relief

    • Cough
    • Runny, stuffy nose
    • Itchy throat

    For Ages 6 to 11 years

    Alcohol-free

    Grape Flavor

    FL OZ (mL)

    *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Children's Triaminic® Night Time Cold & Cough.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

    5000 KANSAS AVE, KANSAS CITY, KS 66106

  • Package Label

    Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

    BEST CHOICE Children's Triacting Night Time Cold & Cough Grape Flavor

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND COUGH  CHILDRENS
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-984
    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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-984-041 in 1 BOX06/10/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/10/2022
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)
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