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 ALTANTIC BIOLOGICALS CORP.. 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179   

PRINCIPAL DISPLAY PANEL

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: 17856-0134(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: 17856-0134-1	72 in 1 BOX, UNIT-DOSE	03/05/2020
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-0134-2	72 in 1 BOX, UNIT-DOSE	03/05/2020
2		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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

Labeler - ALTANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ALTANTIC BIOLOGICALS CORP.		047437707	relabel(17856-0134) , repack(17856-0134)