Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

TRIAMINIC COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin liquid 
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 ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purposes

Cough suppressant
Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• 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

• cough persists for more than 7 days, comes back, or occurs with 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:

  2.5 mL to 5 mL

• children 6 to under 12 years of age:

  5 mL to 10 mL

Other information

• store at controlled room temperature 20-25°C (68-77°F). Protect from light.
• do not refrigerate
• close cap tightly

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

call 1-800-452-0051

Principal Display Panel

NDC: 0067-8118-04

Triaminic®

Children’s

Cough & Congestion

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

• Cough
• Chest Congestion
• Thins & Loosens Mucus

Ages 4 to 11 Years

Syrup

Cherry 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

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.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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.

12673

TRIAMINIC  COUGH AND CONGESTION
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-8118
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (Dark Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-8118-04	1 in 1 CARTON	06/20/2014	12/08/2017
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	06/20/2014	12/08/2017

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

Revised: 8/2019

Document Id: 10616389-0892-4f32-a29c-aa4f16e49768

34390-5

Set id: 85cdcb69-2336-4e36-9f24-711d391f3215

Version: 3

Effective Time: 20190820

 

GlaxoSmithKli