SILTUSSIN DM DAS COUGH FORMULA- guaifenesin and dextromethorphan hydrobromide liquid
Lannett Company, 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 DAS Cough Formula

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

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

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan HBr: 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

  • 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


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

* 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

bottle label
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)

Revised: 5/2019
Document Id: b33ffe71-507a-401a-90c3-738292fab232
Set id: 22f0e46f-b98c-4b7a-957a-fe49565fa41e
Version: 16
Effective Time: 20190529
Lannett Company, Inc.