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Childrens Triacting Nighttime Cold and Cough

Medically reviewed on November 6, 2017

Dosage form: liquid
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL, DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-301

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 Facts

Active ingredients (in each 5 m)

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 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.
  • 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
  • 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 exceed recommended dosage
  • 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 give more than 6 doses in 24 hours unless directed by a doctor.
  • mL = milliliter
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
 Age Dose
 children 6 to under 12 years10 mL every 4 hours 
 children 4 to under 6 yearsdo not use unless directed by a doctor
 children under 4 years of age do not use

Other information
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F) 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 1-248-449-9300 Monday-Friday 9AM-5PM EST 

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 distributors 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.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

Quality Choice Children's Triacting Nighttime Cold & Cough Liquid

CHILDRENS TRIACTING NIGHTTIME  COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-301
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
SODIUM BENZOATE 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
PROPYLENE GLYCOL 
WATER 
TRISODIUM CITRATE DIHYDRATE 
FD&C BLUE NO. 1 
MALTITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-301-041 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/30/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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