TRIAMINIC LONG ACTING COUGH- 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.

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Drug Facts

Active ingredient

Dextromethorphan HBr 7.5 mg

Purpose

Cough Suppressant

Uses

● temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

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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 the child’s prescription 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)

● cough that persists or is chronic such as occurs with asthma

Stop use and ask a doctor if

● cough persist for more than 7 days, comes back or occurs with a fever, rash, or persistent headache. These could be signs of a medical 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 6 to 8 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.

Other information

● each teaspoonful contains: sodium 7 mg

● protect from light

● store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

benzoic acid, citric acid, dibasic sodium phosphate, edetate disodium, flavors, propylene glycol, purified water, sorbitol, sucrose

Package/Label Principal Display Panel

TRIAMINIC LONG ACTING COUGH
dextromethorphan hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-6350
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-6350-04	1 in 1 CARTON	12/08/2011	08/31/2014
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/08/2011	08/31/2014

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

Revised: 3/2017

Document Id: 131553cf-d99c-4297-ae3b-d9ba41cf8151

Set id: 83bb1f25-23e8-4827-bfc4-25ff3c87de18

Version: 2

Effective Time: 20170308

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC