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

Age	Dose
children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	2 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-6344
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description
1	NDC:0067-6344-04	1 BOTTLE (BOTTLE) in 1 CARTON
1		118 mL in 1 BOTTLE
2	NDC:0067-6344-08	1 BOTTLE (BOTTLE) in 1 CARTON
2		236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/26/2008

Labeler - Novartis Consumer Health, Inc. (879821635)

Establishment
Name	Address	ID/FEI	Operations
Novartis Consumer Health		129836151	MANUFACTURE, ANALYSIS

Revised: 04/2011

Document Id: 00f66f25-3469-4c16-9baf-fba21e9628bd

Set id: 00f66f25-3469-4c16-9baf-fba21e9628bd

Version: 1

Effective Time: 20110426

Novartis Consumer Health, Inc.

Further information

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

Medical Disclaimer

TRIAMINIC Childrens Night Time Cold and Cough

Further information

See also:

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Zepbound

Ozempic

Wegovy

Victoza

Saxenda

Alli

Methamphetamine

Amphetamine

Phentermine