Label: DAYTIME NIGHTTIME COLD AND COUGH CHILDRENS- dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit

  • Category: HUMAN OTC DRUG LABEL

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 13, 2019

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  • Active ingredients DayTime  (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Active ingredients for Nighttime (in each 5 mL)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purposes for Day Time

    Cough suppressant

    Nasal decongestant

  • Purpose for Night Time

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    DAYTIME

    • temporarily relieves
      • nasal and sinus congestion 
      • cough due to minor throat and bronchial irritation as may occur with a cold

    NIGHTTIME

    •   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

    DAYTIME

    • 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.

    NIGHTTIME

    • in a child under 4 years of age
    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs 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

    DAYTIME

    • 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

    NIGHTTIME

    • 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

    NIGHTTIME

    taking sedatives or tranquilizers.

    When using this product

    DAYTIME

    do not exceed recommended dosage.

    NIGHTTIME

    • 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

    DAYTIME

    • nervousness, dizziness or sleeplessness occur
    • 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.

    NIGHTTIME

    • nervousness, dizziness, or sleeplessness occur
    • 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.

    DAYTIME

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

    NIGHTTIME

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

  • Directions

    DAYTIME

    • 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
    agedose
     children 6 to under 12 years of age10 mL every 4 hours
     children 4 to under 6 years of age5 mL every 4 hours
     children under 4 years of agedo not use


    NIGHTTIME

    • 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 age10 mL every 4 hours
    children 4 to under 6 years of agedo not use unless directed by a doctor
    children under 4 years of age do not use

  • Other information

    DAYTIME

    • each 5 mL contains: sodium 2 mg
    • store between 20-25ºC (68º-77ºF). Do not refrigerate.

    NIGHTTIME

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

    Inactive ingredients for Day Time 

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

    Inactive ingredients for Night Time 

    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® Day Time Cold & Cough*

    Daytime

    Children's

    Cold & Cough

    DEXTROMETHORPHAN HBr  Cough suppressant

    PHENYLEPHRINE HCl Nasal decongestant

    Relieves

    • Cough
    • Stuffy nose

    Alcohol  0.14%

    For Ages 4 to 11 Years

    Cherry Flavor

    Dosage cup included

    FL OZ (mL)

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

    Children's

    Nighttime Cold & Cough

    DIPHENHYDRAMINE HCI  Antihistamine; Cough suppressant

    PHENYLEPHRINE HCl  Nasal decongestant

    Relieves

    • Cough
    • Runny, stuffy nose
    • itchy throat

    Alcohol free

    For Ages 6 to 11 Years

    Grape Flavor

    Dosage cup included

    FL OZ (mL)

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS.com

  • Product Label

    Dextromethorphan HBr 5 mg, Phenylephrine HCl 2.5 mg, Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

    CVS HEALTH Daytime and Nighttime Cold and Cough

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD AND COUGH  CHILDRENS
    dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-422
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-422-081 in 1 KIT; Type 0: Not a Combination Product04/30/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    DAYTIME COLD COUGH  CHILDRENS
    dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    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
    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 FINALpart34104/30/2018
    Part 2 of 2
    NIGHT TIME COLD AND COUGH  CHILDREN
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    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)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 FINALpart34104/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/30/2018
    Labeler - CVS Pharmacy (062312574)