CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-368-04
Set ID a16514dd-6eee-4c33-b6b1-d8a7eece6aa6
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL, 1 teaspoonful)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Antihistamine/Cough suppressant

    Nasal decongestant 

  • Uses

    • temporarily relieves:
      • sneezing
      • running nose
      • itchy nose or throat
      • 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

    • to make a child sleepy 
    • 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 the 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

    Ask a doctor before use if the child has

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

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product,

    • do not use more than directed
    • marked drowsiness may occur
    • 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 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 take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • tsp = teaspoon, mL = milliliter
     age dose
     children 6 to 11 years 2 tsp (10 mL) every 4 hours
     children 4 to 5 yearsdo not use unless directed by a doctor
     children under 4 years do not use
  • Other information

    • each 5 mL contains: sodium 6 mg
    • contains no aspirin
    • protect from light
    • store at 20º-25°C (68º-77°F). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA,Fd&C blue #1,  FD&C red #40, maltitol solution, natural & artificial flavor, propylene glycol, purified water, sodium citrate

  • Principal Display Panel

    *Compare to the active ingredients in Children's Triaminic® Nighttime Cold & Cough

    Children's Triacting Nighttime

    Cold & Cough

    Diphenhydramine HCl

    Antihistamine

    Cough Suppressant

    Phenylephrine HCl

    Nasal Decongestant

    For Ages 6 to 11

    Grape Flavor

    FL OZ (mL)

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Children's Triaminic® Night Time Cold & Cough.

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

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions:248-449-9300

  • Package Label

     Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

    Childrens Triacting Nighttime Cold and Cough

  • INGREDIENTS AND APPEARANCE
    CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH 
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-368
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MALTITOL (UNII: D65DG142WK)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-368-041 in 1 BOX05/30/201412/30/2021
    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 FINALpart34105/30/201412/30/2021
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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