SILTUSSIN DM - guaifenesin and dextromethorphan hydrobromide liquid 
Silarx Pharmaceuticals,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.


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



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.


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 years DO 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,

1033 Stoneleigh Ave.
Carmel, NY 10512

Container label 118 mL

guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-209
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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 dihydrate (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-209-40 118 mL in 1 BOTTLE, PLASTIC
2 NDC:54838-209-70 237 mL in 1 BOTTLE, PLASTIC
3 NDC:54838-209-80 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/05/1992
Labeler - Silarx Pharmaceuticals,Inc (161630033)

Revised: 6/2014
Document Id: 0acdbd81-2461-4fe0-99fb-72727a8e83a4
Set id: 7402358e-8234-472f-aa6d-cee9550662f8
Version: 16
Effective Time: 20140627
Silarx Pharmaceuticals,Inc