Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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 AND ALLERGY
brompheniramine maleate, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-8117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE (clear bluish-red)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-8117-04	1 in 1 CARTON	09/20/2013	05/29/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/20/2013	05/29/2015

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2019

Document Id: 49b3dd3e-495c-4221-a973-a8db648844fe

34390-5

Set id: 0da4b415-6aaf-4c64-9c1c-f59e7edc4db2

Version: 2

Effective Time: 20190830

 

GlaxoSmithKli