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TRIAMINIC Childrens Night Time Cold and Cough

Dosage form: syrup
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Novartis Consumer Health, Inc.
NDC code: 0067-6344

Drug Facts

Active ingredient

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5

Purpose

Antihistamine/cough suppressant

Nasal decongestant

Uses
  • temporarily relieves

    • sneezing • itchy nose or throat • runny nose

    • 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
  • 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

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 right away.

Directions
  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
  • find the right dose on chart below.
  • use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device
AgeDose
children under 4 years of agedo not use
children 4 to under 6 years of agedo not use unless directed by a doctor
children 6 to under 12 years of age2 teaspoonfuls (10 mL)

Other informaton
  • each teaspoonful contains: sodium 6 mg
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, maltitol solution, propylene glycol, purified water, sodium citrate

Questions or comments?

call 1-800-452-0051 24 hours a day, 7 days a week

Additional information listed

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE:

DO NOT USE IF SAFETY SEAL IMPRINTED WITH “TRIAMINIC” AROUND BOTTLE CAP IS BROKEN OR MISSING.

For more information plus helpful tips visit www.triaminic.com

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20xx

Package/Label Principal Display Panel

TRIAMINIC  CHILDRENS NIGHT TIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6344
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
BENZOIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
SODIUM CITRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:0067-6344-041 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0067-6344-081 BOTTLE (BOTTLE) in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/2008
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIOperations
Novartis Consumer Health129836151MANUFACTURE, ANALYSIS

Revised: 04/2011
 
Novartis Consumer Health, Inc.

Further information

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