TRIAMINIC CHILDRENS COLD AND ALLERGY- chlorpheniramine maleate, 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

Chlorpheniramine maleate 1 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves
 
• itchy, watery eyes • runny nose • itchy nose or throat
 
• sneezing • nasal and sinus congestion 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.

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

• a breathing problem such as asthma or 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 using this product

nervousness, dizziness or sleeplessness occurs

symptoms do not improve within 7 days or occur with a fever. 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

do not use unless directed by a doctor

children 6 to under 12 years of age

2 teaspoonfuls (10 mL)

Other information

each teaspoonful contains: sodium 3 mg  
store at controlled room temperature  20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, FD&C yellow #6, flavors, maltitol solution, purified water, sodium citrate

Questions or comments?

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

Additional information

Child-Resistant Safety Cap. Tamper Evident Feature: Do not use if safety seal imprinted with “Triaminic” around the bottle cap is broken or missing.

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

Trusted by Parents for over 50 years. (Depending on space availability)

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. (Depending on space availability)

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008 2004346

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TRIAMINIC  CHILDRENS COLD AND ALLERGY
chlorpheniramine maleate, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTITOL (UNII: D65DG142WK)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6346-041 in 1 CARTON09/26/200805/31/2014
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/200805/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 9/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC