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TRIAMINIC Night Time Cold and Cough

Dosage form: syrup
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0067-8106

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 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

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
may cause marked drowsiness
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
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

10 mL

Other information
each 5 mL contains: sodium 3 mg
store at 20-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

call 1-800-452-0051

Distributed by:

GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies

or its licensor. All rights reserved.

Principal Display Panel

NDC 0067-8106-04

Ages 6 to 11 years

Children’s Triaminic® Syrup

Night Time Cold & Cough

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Cough Relief
Runny, Stuffy Nose
Itchy Throat

Grape Flavor

4 Fl OZ (118 mL)

Child-Resistant Safety Cap.

Do not use if printed neckband is broken or missing.

What You Need to Help Make Your Child Feel Better

Night Time Cold & Cough

Cough Relief
Runny, Stuffy Nose
Itchy Throat

The Triaminic brand provides a broad range of products, created with the needs of children in mind.

Trusted by Parents for over 50 years.

For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic®, 1-800-

KIDS-987

12682

TRIAMINIC  NIGHT TIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8106
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 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
Packaging
#Item CodePackage Description
1NDC:0067-8106-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/2012
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on Apr 24, 2018

Further information

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

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