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NDC 54838-0209-70 Siltussin DM 10; 100 mg/5mL; mg/5mL Details

Siltussin DM 10; 100 mg/5mL; mg/5mL

Siltussin DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Lannett Company, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 54838-0209-70
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 54838-0209-70
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	54838-0209
Product ID	54838-209_39e6fbaa-ce27-41ba-bb09-e86e363da87f
Associated GPIs	43997002521220
GCN Sequence Number	016414
GCN Sequence Number Description	guaifenesin/dextromethorphan SYRUP 100-10MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53495
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Siltussin DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Dextromethorphan Hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	10; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Lannett Company, Inc.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 54838-0209-70 (54838020970)

Pricing Information
NDC Package Code	54838-209-70
Billing NDC	54838020970
Package	237 mL in 1 BOTTLE, PLASTIC (54838-209-70)
Marketing Start Date	1992-09-05
NDC Exclude Flag	N
Price Per Unit	0.03072
Pricing Unit	ML
Effective Date	2023-12-20
NDC Description	SILTUSSIN DM COUGH SYRUP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 7402358e-8234-472f-aa6d-cee9550662f8 Details

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

SPL UNCLASSIFIED 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

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

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

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

ask a health professional before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

SPL UNCLASSIFIED 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

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

SPL UNCLASSIFIED SECTION

Questions: 888-974-5279

Manufactured by

Silarx Pharmaceutical Inc,

1033 Stoneleigh Ave.

Carmel, NY 10512

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILTUSSIN DM

guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54838-209
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (STRAWBERRY FLAVOR)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54838-209-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/1992	12/31/2023
2	NDC:54838-209-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/1992	11/30/2023
3	NDC:54838-209-80	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2023	11/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/05/1992	12/31/2023

Labeler - Lannett Company, Inc. (002277481)

Revised: 6/2014

Document Id: 39e6fbaa-ce27-41ba-bb09-e86e363da87f

Set id: 7402358e-8234-472f-aa6d-cee9550662f8

Version: 18

Effective Time: 20140627

Search by Drug Name or NDC

NDC 54838-0209-70 Siltussin DM 10; 100 mg/5mL; mg/5mL Details

Siltussin DM 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 54838-0209-70 (54838020970)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7402358e-8234-472f-aa6d-cee9550662f8 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding

SPL UNCLASSIFIED SECTION

Directions

SPL UNCLASSIFIED SECTION

Other information

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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