Siltussin DM DAS Cough Formula

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

OTC - PURPOSE SECTION

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan HBr: Cough Suppressant

INDICATIONS & USAGE SECTION

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
  
• helps loosen phlegm (mucus)
  
• thin bronchial secretions to make coughs more productive
  

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

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
  

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

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

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8143-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• Siltussin DM DAS Cough Formula
• Guaifenesin and Dextromethorphan Hydrobromide
• GUAIFENESIN
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• ANHYDROUS CITRIC ACID
• GLYCERIN
• MENTHOL, UNSPECIFIED FORM
• METHYLPARABEN
• PROPYLENE GLYCOL
• SACCHARIN SODIUM
• SODIUM BENZOATE
• SORBITOL
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.