CHILDRENS TRIACTING NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid 
QUALITY CHOICE (Chain Drug Marketing Association)

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.

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Drug Facts

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

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)

Revised: 11/2019
 
QUALITY CHOICE (Chain Drug Marketing Association)