LEADER TUSSIN DM - dextromethorphan hydrobromide and guaifenesin liquid
Cardinal Health

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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Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 tsp every 4 hours
children under 12 years	do not use

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Robitussin® DM active ingredients

For Ages 12 & Over

Adult

Tussin DM

Cough & Chest Congestion

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Relieves:

Coughs

Chest Congestion Mucus

Non-Drowsy

See New Dosing Directions

Alcohol Free

Tussin DM Carton Image 1

Tussin DM Carton Image 2

LEADER TUSSIN DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-970
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-970-26	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		118 mL in 1 BOTTLE	This package is contained within the CARTON (37205-970-26)
2	NDC:37205-970-34	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		237 mL in 1 BOTTLE	This package is contained within the CARTON (37205-970-34)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/21/1991

Labeler - Cardinal Health (097537435)

Revised: 01/2012 Cardinal Health