COUGH SUPPRESSANT AND EXPECTORANT DM- tussin dm liquid

Cough Suppressant and Expectorant DM by

Drug Labeling and Warnings

Cough Suppressant and Expectorant DM by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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 cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

• 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 more than 7 days, comes back, or accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

• Do not take more than 6 doses in a 24-hour period
• Repeat dose every 4 hours while symptoms last

          AGE                                     DOSE

adults and children

12 years of age and over               10 mL    

children 6 years to

under 12 years of age                    5 mL

children 2 years to

under 6 years of age                      2.5 mL

children under

under 2 years of age                      ask a doctor

Other information

• Store at 15-30°C (59-86°F)
• Protect from freezing
• Alcohol free
• Protect from light
• Each teaspoon 5mL contains: Sodium 3 mg

Inactive ingredients

citric acid, dextrose**, flavor, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium,
sodium benzoate

** contains one or more of these ingredients

Principal Display Panel

Compare to the Active Ingredients in Robitussin DM

Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

cough suppressant, expectorant

Non-Drowsy

Alcohol Free

Relieves- coughs, chest congestion and mucus

2 FL Oz (60 mL)

INGREDIENTS AND APPEARANCE

COUGH SUPPRESSANT AND EXPECTORANT DM 
tussin dm liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-044
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-044-01	1 in 1 CARTON	06/29/2016
1		60 mL in 1 BOTTLE, PLASTIC; 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	06/29/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-044)