TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by davAgen Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5 mL tsp):	Purpose
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Guaifenesin, USP 100 mg	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) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Do not exceed recommended dose

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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.

Other information

Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.

Inactive ingredients

citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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
• mL = milliliter; tsp = teaspoonful

age	dose
adults and children 12 years and over	10 mL (2 tsp) every 4 hours
children under 12 years	do not use

SPL UNCLASSIFIED SECTION

Manufactured by:
davAgen
Pharmaceutical LLC
Somerset, NJ 08873

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

davAgen
pharmaceutical

NDC: 76140-106-08

Adults & Children Ages 12 & Older

Tussin DM
Cough &
Chest Congestion

Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin

For Relief of:

• Cough
• Chest Congestion & Mucus

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

TUSSIN DM 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76140-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Benzoate (UNII: OJ245FE5EU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sorbitol (UNII: 506T60A25R)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sucralose (UNII: 96K6UQ3ZD4)
FD&C Red No. 40 (UNII: WZB9127XOA)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Sodium Citrate (UNII: 1Q73Q2JULR)
Menthol (UNII: L7T10EIP3A)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH, ORANGE, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76140-106-08	1 in 1 CARTON
1		236 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/10/2013

Labeler - davAgen Pharmaceutical, LLC (967545935)

Establishment
Name	Address	ID/FEI	Business Operations
davAgen Pharmaceutical, LLC		967545935	MANUFACTURE(76140-106) , PACK(76140-106) , LABEL(76140-106) , ANALYSIS(76140-106)