TRIAMINIC DAY TIME COLD AND COUGH- dextromethorphan hbr, phenylephrine hcl syrup 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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 ingredient (in each 5 mL, 1 teaspoonful)

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Nasal decongestant 

Uses

temporarily relieves

• 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.

Ask Doctor before use if your child has

heart disease • high blood pressure
thyroid disease • diabetes
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma

When using this product

do not exceed recommended dosage

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

Age

Dose

children under 4 years of age

do not use

children 4 to under 6 years of age

1 teaspoonful (5 mL)

children 6 to under 12 years of age

2 teaspoonfuls (10 mL)

Other information

each teaspoonful contains: sodium 2 mg
store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, 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 on Other Panels

See New Directions and Warnings Information 

Children’s

Triaminic®

Syrup

Day Time Cold & Cough

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Stuffy Nose
Cough

PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org

 

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE:

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

 

Triaminic® Has More Ways to Help Kids Feel Better!

Great Tasting Liquids

Free Dosage Cup (enclosed)
Alcohol Free

Fast-Dissolving Softchews®

Great Taste

Convenient Thin Strips®

Melts in an Instant
Easy to Give/Easy to Take
No Mess Dosing

information plus hS-987

24 hours a day, 7 days a week

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

Trusted by Parents for over 50 years.

What You Need to Make Your Child Feel Better!  

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

1-800-KIDS-987 24 hours a day, 7 days a week.

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20xx

Principal Display - Cherry

Children's Triaminic Day Time Cold & Cough

Children's Triaminic Day Time Cold & Cough Syrup

TRIAMINIC  DAY TIME COLD AND COUGH
dextromethorphan hbr, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CHERRY (UNII: BUC5I9595W)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6345-041 in 1 CARTON11/01/201103/31/2014
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 finalpart34111/01/201103/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC