TRIAMINIC COUGH AND SORE THROAT- acetaminophen, dextromethorphan hbr 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.

----------

Drug Facts

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Dextromethorphan HBr 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Uses

temporarily relieves minor aches and pains
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

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 a 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. Prompt medical attention is critical for adults as well as children 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
may be given every 4 hours. Do not give more than 5 doses in 24 hours unless directed by a doctor.
find the right dose on chart below.
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 under 4 to under 6 years of age

1 teaspoonful (5 mL)

Children under 6 to under 12 years of age

2 teaspoonful (10 mL)

Other information

each teaspoonful contains: sodium 5 mg
contains no aspirin
store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucrose

Questions or comments?

call 1-800-452-0051

Additional information listed on other panels

PARENTS: Learn about teen medicine abuse.
www.StopMedicineAbuse.org

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE:

DO NOT USE IF SAFETY SEAL IMPRINTED WITH “TRIAMINIC”

AROUND BOTTLE CAP IS BROKEN OR MISSING.

Triaminic® Has More Ways to Help Kids Feel Better.

Great Tasting Liquids

Free Dosage Cup (enclosed)
Alcohol - Free

Thin Strips®

Melts in an Instant
Easy to Give/Easy to Take
No Mess Dosing

What You Need to Make Your Child Feel Better!

For more information plus helpful tips visit www.triaminic.com

Distr. by: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622 ©20XX

Principal Display Panel

0067-6348-04

Children’s Triaminic® Syrup
Cough & Sore Throat

Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)

Cough
Sore Throat

Grape FLAVOR

Triaminic Cough & Sore Throat 4 oz carton
TRIAMINIC  COUGH AND SORE THROAT
acetaminophen, dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6348
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6348-041 in 1 CARTON09/06/200809/30/2013
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 finalpart34109/06/200809/30/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC