Siltussin DM Cough Syrup

Manufacturer: Preferred Pharmaceuticals, Inc
Effective date: 2020-09-17
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: legacy-cache
Hydrated at: 2026-08-01 23:15:08

Label at a glance#

ProductSiltussin DM

Active ingredientGuaifenesin, Dextromethorphan Hydrobromide

Label structure13 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)

Contacts and useful links#

PhoneLabel contact888-974-5279

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

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-209-40	ML - Milliliter	54838-209	2a79c797-f8c4-48c8-a110-26eed9ad8be7	1	2012-07-24
54838-209-70	ML - Milliliter	54838-209	a5523419-d07f-4de9-adec-11fe414b0f7d	1	2012-07-24
54838-209-80	ML - Milliliter	54838-209	ae86356e-d41f-40f9-b1e0-ae8eb5820908	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	10
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	10
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	10
Guaifenesin	ACTIVE MOIETY	495W7451VQ	10
citric acid	INACTIVE INGREDIENT	2968PHW8QP	10
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	10
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	10
menthol	INACTIVE INGREDIENT	L7T10EIP3A	10
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	10
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	10
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	10
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	10
sucrose	INACTIVE INGREDIENT	C151H8M554	10
water	INACTIVE INGREDIENT	059QF0KO0R	10

Products#

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

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

Siltussin DM
Guaifenesin and Dextromethorphan Hydrobromide
Guaifenesin
Dextromethorphan Hydrobromide
Dextromethorphan
CITRIC ACID MONOHYDRATE
FD&C red no. 40
glycerin
MENTHOL, UNSPECIFIED FORM
methylparaben
propylene glycol
saccharin sodium
sodium benzoate
sucrose
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68788-9103	68788-9103-1
54838-209

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Guaifenesin	495W7451VQ	ACTIB
Dextromethorphan Hydrobromide	9D2RTI9KYH	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C red no. 40	WZB9127XOA	IACT
glycerin	PDC6A3C0OX	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
methylparaben	A2I8C7HI9T	IACT
propylene glycol	6DC9Q167V3	IACT
saccharin sodium	SB8ZUX40TY	IACT
sodium benzoate	OJ245FE5EU	IACT
sucrose	C151H8M554	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 9 · 492 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		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
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 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	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
citric acid	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 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
7d566d39-cc5a-43e7-ad60-d9c1dc14f365			9dc928f7-d07e-4b1e-ae12-18a2fbd3226b	2021-09-14	Warnings	Exact identifier spl set id: 9dc928f7-d07e-4b1e-ae12-18a2fbd3226b

Reported adverse events (FAERS/openFDA)#

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