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.

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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

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 (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)

Questions: 888-974-5279


Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave.
Carmel, NY 10512


Container label 118 mL


SILTUSSIN DM 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-209
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
FD&C red no. 40 
glycerin 
menthol 
methylparaben 
propylene glycol 
saccharin sodium dihydrate 
sodium benzoate 
sucrose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (STRAWBERRY FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-209-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-209-70237 mL in 1 BOTTLE, PLASTIC
3NDC:54838-209-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/05/1992
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