Siltussin DM DAS Cough Formula

Manufacturer: Lannett Company, Inc.
Effective date: 2019-05-29
Label type: HUMAN OTC DRUG LABEL
Version: 17
Source: legacy-cache
Hydrated at: 2026-08-01 21:56:25

Label at a glance#

ProductSiltussin DM DAS Cough Formula

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 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)

Contacts and useful links#

PhoneLabel contact1-844-834-0530

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0354838133400	GTIN-13: 0354838133400 EAN-13: 0354838133400 GTIN-12: 354838133400 UPC-A: 354838133400 GTIN storage (14 digits): 00354838133400	siltussin-dm-das-cough-formula-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-133-40	ML - Milliliter	54838-133	1ccbda76-d4af-41aa-916e-d5142d5dc364	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	14
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	14
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	14
Guaifenesin	ACTIVE MOIETY	495W7451VQ	14
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	14
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	14
menthol	INACTIVE INGREDIENT	L7T10EIP3A	14
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	14
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	14
saccharin sodium dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	14
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	14
sorbitol	INACTIVE INGREDIENT	506T60A25R	14
water	INACTIVE INGREDIENT	059QF0KO0R	14

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
METHYLPARABEN
PROPYLENE GLYCOL
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54838-133	54838-133-40

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 433 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAMUSCULAR		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY, METERED / NASAL	1.2 mg/1ml		Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	OIL / TOPICAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAVENOUS		1152 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
77e74ca8-1539-444b-b810-3115b3a8a154			22f0e46f-b98c-4b7a-957a-fe49565fa41e	2019-05-29	Warnings	Exact identifier spl id: 77e74ca8-1539-444b-b810-3115b3a8a154 spl set id: 22f0e46f-b98c-4b7a-957a-fe49565fa41e

Reported adverse events (FAERS/openFDA)#

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