Siltussin DM DAS Cough Formula

Manufacturer
ALTANTIC BIOLOGICALS CORP.
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:12

Label at a glance#

ProductSiltussin DM DAS Cough Formula
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Dosage and administration

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)

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 yearsDO 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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179   

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0134-12022-01-28C16284748780-1d6a99b39-787b-a426-e053-dadaa90af4c2Siltussin DM DAS Cough Formula
17856-0134-22022-01-28C16284748780-1d6a99b39-787b-a426-e053-dadaa90af4c2Siltussin DM DAS Cough Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0134-1Siltussin DM DAS Cough Formula72 in 1 BOX, UNIT-DOSELIQUID722
17856-0134-1Siltussin DM DAS Cough Formula5 mL in 1 CUP, UNIT-DOSELIQUID52
17856-0134-2Siltussin DM DAS Cough Formula10 mL in 1 CUP, UNIT-DOSELIQUID102
17856-0134-2Siltussin DM DAS Cough Formula72 in 1 BOX, UNIT-DOSELIQUID722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0134SILTUSSIN DM DAS COUGH FORMULA (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [ALTANTIC BIOLOGICALS CORP.]2Legacy NDC, 4 package rows20200730_fc55ad78-97e5-42b7-a6d2-433b5a7bdef3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-133-40ML - Milliliter54838-1331ccbda76-d4af-41aa-916e-d5142d5dc36412012-07-24

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-013417856-0134-1, 17856-0134-2
54838-133

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4ebd7ead-873a-4317-9fe5-2186934075a2fc55ad78-97e5-42b7-a6d2-433b5a7bdef32020-07-29WarningsExact identifier
spl id: 4ebd7ead-873a-4317-9fe5-2186934075a2
spl set id: fc55ad78-97e5-42b7-a6d2-433b5a7bdef3

Reported adverse events (FAERS/openFDA)#

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