SILTUSSIN DM DAS COUGH FORMULA- guaifenesin and dextromethorphan hydrobromide liquid

Siltussin DM DAS Cough Formula by

Drug Labeling and Warnings

Siltussin DM DAS Cough Formula by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Active Ingredient: Dextromethorphan HBr 10 mg (in each 5 mL (teaspoonful)(TSP))

PURPOSE

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan HBr: Cough Suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
  
• helps loosen phlegm (mucus)
  
• 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

• persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
  
• hypersensitive to any ingredients
  

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

• take every 4 hours, or as directed by a doctor
  
• do not take more than 6 doses in 24 hours

• Adults and children 12 years and over: 2 teaspoonfuls (TSP)(10 mL)
• Children under 12 years: DO NOT USE

Other information

store at room temperature between 15°-30°C (59°-86°F)

Inactive ingredients

citric acid, strawberry flavor, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Questions

1-844-834-0530

SPL UNCLASSIFIED SECTION

* This product is not manufactured or distributed by Whitehall Robins, distributor of Robitussin®-DM.

Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512

10-1042   Rev. 03/18

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILTUSSIN DM DAS COUGH FORMULA 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-133
Route of Administration	ORAL

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)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (strawberry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-133-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/05/1995

Labeler - Lannett Company, Inc. (161630033)