Label: TRIACTING DAYTIME COLD COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl syrup

  • NDC Code(s): 63868-369-04
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • 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 May 2, 2023

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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Phenylephrine HCL 2.5 mg

  • Purposes

    Cough suppressant

    Nasal decongestant 

  • Uses

    • temporarily relieves:
      • 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

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

    When using this product,

    do not exceed recommended dosage.

    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 any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • shake well before using
     age dose
     children 6 to under 12 years of age 10 mL every 4 hours
     children 4 to under 6 years of age 5 mL every 4 hours
     children under 4 years of age do not use
  • Other information

    • each 5 mL contains: sodium 2 mg
    • store between 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate

  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    *Compare to the Active Ingredients in Children's Triaminic® Day Time Cold & Cough

    Children's Triacting Daytime

    Cold and Cough

    Dextromethorphan HBr

    Cough Suppressant

    Phenylephrine HCL

    Nasal Decongestant

    For Ages 4 to 11

    Alcohol 0.14%

    Cherry Flavor

     FL OZ (mL)

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

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

    Distributed by C.D.M.A., Inc.©

    43157 W. 9 Mile Rd

    Novi, MI 48376-0995

    www.qualitychoice.com 

    Questions: 248-449-9300

  • Package Label

    Dextromethorphan HBr 5 mg, Phenylephrine HCL 2.5 mg

    QUALITY CHOICE Children's Triacting Daytime Cold & Cough

  • INGREDIENTS AND APPEARANCE
    TRIACTING DAYTIME COLD COUGH  CHILDRENS
    dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-369
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-369-041 in 1 BOX05/30/201405/30/2024
    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 finalpart34105/30/201405/30/2024
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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