TUSSIN DM - guaifenesin and dextromethorphan hydrobromide liquid 
Physicians Total Care, Inc.

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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Tussin DM Cough Syrup

Active Ingredient: Guaifenesin 100 mg (in each 5 mL)

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

Uses

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

Stop use and ask a doctor if

If pregnant or breast-feeding

 

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

Adults and children 12 years and over
2 teaspoonfuls (10 mL)
every 4 hours
Children under 12 yearsDO NOT USE

Inactive ingredients

citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

Other information

store at room temperature 20°-25°C (68°-77°F)

Questions: 888-974-5279


Manufactured by

Silarx Pharmaceutical Inc,

19 West Street , Spring Valley

NY - 10977- USA.


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, OK      74146


Tussin-DM (OTC)

NDC 54868-1934-2

237 mL

image of package label


TUSSIN DM 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1934(NDC:54838-209)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid (UNII: 2968PHW8QP)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
menthol (UNII: L7T10EIP3A)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (STRAWBERRY FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-1934-1118 mL in 1 BOTTLE, PLASTIC
2NDC:54868-1934-2237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/03/2009
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 6/2011
Document Id: 9c4972f6-6db3-468b-be1a-1af272dd1ed3
Set id: 71e383f3-8c7e-4140-bdc9-114c31a8806f
Version: 1
Effective Time: 20110617
 
Physicians Total Care, Inc.