SILTUSSIN DM  - guaifenesin and dextromethorphan hydrobromide liquid 
TYA Pharmaceuticals

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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Siltussin DM Cough Syrup

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

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

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

Uses

Warnings

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. Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding

. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

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 (TSP) 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)

888-974-5279 Questions:


Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave. Carmel, NY 10512

Label Image
SILTUSSIN DM  
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0209(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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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:64725-0209-18 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/05/1992
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-0209) , REPACK(64725-0209)

Revised: 6/2014
Document Id: 8ec7115c-b3e2-428b-9bb8-8e6516054381
Set id: ad9916ec-633b-4dcd-a955-88d5f0ec439e
Version: 2
Effective Time: 20140627
 
TYA Pharmaceuticals