Friday, October 21, 2016

Tussin DM



dextromethorphan hydrobromide and guaifenesin

Dosage Form: oral liquid
Drug Facts

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 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 TypeHUMAN OTC DRUGNDC Product Code (Source)68016-018
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan)Dextromethorphan Hydrobromide10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN)GUAIFENESIN100 mg  in 5 mL




















Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
DEXTROSE 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C RED NO. 40 


















Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
168016-018-04118 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2009


Labeler - Premier Value (101668460)

Registrant - Aaron Industries, Inc. (101896231)









Establishment
NameAddressID/FEIOperations
Aaron Industries, Inc.101896231manufacture, analysis
Revised: 11/2009Premier Value




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