Siltussin DM Cough Syrup

Manufacturer
A-S Medication Solutions
Effective date
2019-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:03

Label at a glance#

ProductSiltussin DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Dosage and administration

do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age  Adults and children 12 years and over  2 teaspoonfuls (TSP) every 4 hours   Children under 12 years   DO NOT USE

Storage and handling

store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoon)(TSP))

OTC - PURPOSE SECTION

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

INDICATIONS & USAGE SECTION

Uses

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

Warnings

WARNINGS 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • 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

do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

 Adults and children 12 years and over
 2 teaspoonfuls (TSP)
every 4 hours
 Children under 12 years  DO NOT USE

INACTIVE INGREDIENT SECTION

Inactive ingredients

citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

Other information

STORAGE AND HANDLING SECTION

store at room temperature 20°-25°C (68°-77°F)

OTC - QUESTIONS SECTION

Questions: 888-974-5279


Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave.
Carmel, NY 10512

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4225

NDC: 50090-4225-0 118 mL in a BOTTLE, PLASTIC

Guaifenesin and Dextromethorphan Hydrobromide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4225-02023-01-30C16284748780-1f386c64a-043a-0266-e053-dadaa90a7c1aSiltussin DM Cough Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4225-0Siltussin DM118 mL in 1 BOTTLE, PLASTICLIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4225SILTUSSIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190402_7659ca27-5c5b-436a-b088-76535503f3af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-209-40ML - Milliliter54838-2092a79c797-f8c4-48c8-a110-26eed9ad8be712012-07-24
54838-209-70ML - Milliliter54838-209a5523419-d07f-4de9-adec-11fe414b0f7d12012-07-24
54838-209-80ML - Milliliter54838-209ae86356e-d41f-40f9-b1e0-ae8eb582090812012-07-24

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-422550090-4225-0
54838-209

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
e18fe3e0-c661-477a-8da7-b85f5a06cb997659ca27-5c5b-436a-b088-76535503f3af2019-03-29WarningsExact identifier
spl id: e18fe3e0-c661-477a-8da7-b85f5a06cb99
spl set id: 7659ca27-5c5b-436a-b088-76535503f3af

Reported adverse events (FAERS/openFDA)#

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