Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

TRIAMINIC COUGH AND SORE THROAT- acetaminophen, dextromethorphan hbr suspension 
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.

----------

Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses

• temporarily relieves:
  • minor aches and pains
  • headache
  • minor sore throat pain
  • cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
•   Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
•   If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• in a child under 4 years of age
• if your child is allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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 your child has

• liver disease
• chronic cough that lasts or as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is

• taking the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. 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. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
• use enclosed 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:

  5 mL

• children 6 to under 12 years of age:

  10 mL

Other information

• each 5 mL contains: sodium 3 mg
• contains no aspirin
• store at controlled room temperature 20-25°C (68-77°F). Protect from light.
• close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C red #40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate, xanthan gum

Questions or comments?

call 1-800-452-0051

Principal Display Panel

NDC: 0067-8115-04

Children’s Triaminic Suspension

Cough & Sore Throat

Acetaminophen (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

*Cough

*Sore Throat

Ages 4 to 11 Years

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

PARENTS:

Learn about teen medicine abuse

www.StorpMedicineAbuse.org

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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2016 GSK or its licensor.

12675

TRIAMINIC  COUGH AND SORE THROAT
acetaminophen, dextromethorphan hbr suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-8115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARRAGEENAN (UNII: 5C69YCD2YJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-8115-04	1 in 1 CARTON	07/23/2014	02/09/2017
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	07/23/2014	02/09/2017

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

Revised: 8/2019

Document Id: afd04b5e-2029-4536-a52b-a5152757b739

34390-5

Set id: f61a3668-1526-4124-b203-dc51bc33c201

Version: 3

Effective Time: 20190821

 

GlaxoSmithKli