Tussin DM

Generic Name: dextromethorphan hydrobromide and guaifenesin
Dosage Form: oral liquid

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

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

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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 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 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

When using this product

do not use more than directed

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 this and all drugs out of the reach of children.

In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately.

Directions

do not exceed 6 doses in a 24-hour period
• this adult product is not intended for use in
children under 12 years of age


adults and children 12 years and over    2 teaspoonfuls (tsps) every 4 hours    

children under 12 years   do not use

Other information

alcohol-free • dosage cup provided
• store at controlled room temperature

Inactive ingredients

citric acid, flavor,
glucose, glycerin, high fructose corn syrup,
menthol, purified water, red 40, saccharin sodium,
sodium benzoate

Principal Display Panel

Premier Value
Tussin DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

Controls Coughs
Loosens and Relieves  chest congestion
Alcohol Free
Cough and chest congestion formula for adults

4 fl oz (118mL)

Tussin DM 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-018
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
CITRIC ACID MONOHYDRATE  
DEXTROSE  
GLYCERIN  
HIGH FRUCTOSE CORN SYRUP  
MENTHOL  
SACCHARIN SODIUM  
SODIUM BENZOATE  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68016-018-04 118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/21/2009
Labeler - Premier Value (101668460)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 101896231 manufacture, analysis
Revised: 11/2009
 
Premier Value



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