Diabetic Maximum Strength Siltussin DM DAS-Na

Manufacturer: Lannett Company, Inc.
Effective date: 2014-06-27
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: legacy-cache
Hydrated at: 2026-08-02 01:02:43

Label at a glance#

ProductDiabetic Maximum Strength Siltussin DM DAS-Na

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Dosage and administration

take every 4 hours, or as directed by a doctor, not more than 6 doses in 24 hours Adult and children 12 years and over 2 teaspoonfuls (10 mL) Children under 12 years DO NOT USE

Contacts and useful links#

PhoneLabel contact888-974-5279

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Guaifenesin 200 mg (in each 5 mL)

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

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)
■ 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, not more than 6 doses in 24 hours

Adult and children 12 years and over	2 teaspoonfuls (10 mL)
Children under 12 years	DO NOT USE

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame-K, aspartame, benzoic acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water. May contain citric acid.

Other information

SPL UNCLASSIFIED SECTION

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

■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)

Questions

OTC - QUESTIONS SECTION

888-974-5279

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributor of Robitussin®-DM.

Manufactured by:

Silarx Pharmaceuticals, Inc
1033 Stoneleigh Ave.
Carmel, NY 10512
USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1046631	Dextromethorphan/guaiFENesin (Oral Liquid)	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral Solution	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54838-140-40	ML - Milliliter	54838-140	5e7d4069-422a-4210-8ff8-ac950dc6528e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	12
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	12
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	12
Guaifenesin	ACTIVE MOIETY	495W7451VQ	12
acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	12
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	12
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	12
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	12
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	12
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	12
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	12
water	INACTIVE INGREDIENT	059QF0KO0R	12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Diabetic Maximum Strength Siltussin DM DAS-Na
Guaifenesin and Dextromethorphan Hydrobromide
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
ACESULFAME POTASSIUM
ASPARTAME
BENZOIC ACID
HYPROMELLOSE 2910 (4000 MPA.S)
METHYLPARABEN
PROPYLENE GLYCOL
ANHYDROUS CITRIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54838-140	54838-140-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ASPARTAME	Z0H242BBR1	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	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 6 · 301 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 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	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		107 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	GUM, CHEWING / BUCCAL		147 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 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 / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / SUBLINGUAL		11 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	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	FILM, SOLUBLE / ORAL		10 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
HYPROMELLOSE 2910 (4000 MPA.S)	HYPROMELLOSE 2910 (4000 MPA.S)	RN3152OP35	SHAMPOO / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 21 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	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 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
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
benzoic acid	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
benzoic acid	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 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	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 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
f4311b8a-2123-47f0-8089-16ad5e0db3c8			80b0a591-7e5b-4e47-b96e-8aa888ea1c76	2014-06-27	Warnings	Exact identifier spl set id: 80b0a591-7e5b-4e47-b96e-8aa888ea1c76

Reported adverse events (FAERS/openFDA)#

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