TRIAMINIC COLD AND ALLERGY- brompheniramine 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 (in each 5 mL teaspoonful)

Brompheniramine maleate 1 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves nasal and sinus congestion due to a cold, hay fever or other respiratory allergies
temporarily relieves these symptoms due to hay fever, or other respiratory allergies:
runny nose
sneezing
itchy nose or throat
itchy, watery eyes

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 your 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 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
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 fever

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

2 teaspoonfuls (10 mL)

teaspoonful = tsp

Other information

store at controlled room temperature 20-25°C (68-77°F). Protect from light.
close cap tightly

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

1-800-452-0051

Principal Display Panel

Children’s
Triaminic® Syrup
Cold & Allergy

Brompheniramine maleate (Antihistamine)
Phenylephrine HCl (Nasal Decongestant)

Itchy, Watery Eyes
Runny Nose
Stuffy Nose
Sneezing

Grape Flavor

Triaminic Cold & Allergy Syrup Grape 4 OZ Carton
TRIAMINIC  COLD AND ALLERGY
brompheniramine maleate, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLE (clear bluish-red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8117-041 in 1 CARTON09/20/201305/29/2015
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 finalpart34109/20/201305/29/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2019
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC