Tussin DM Cough and Chest Congestion

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2020-01-02
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:02:46

Label at a glance#

ProductTussin DM Cough and Chest Congestion

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

do not take more than 12 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 softgels every 4 hours children under 12 years do not use

Storage and handling

store at room temperature 15-30°C (59-86°F) avoid excessive heat above 40°C (104°F)

Contacts and useful links#

PhoneLabel contact1-855-215-8180

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 12 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 softgels every 4 hours
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15-30°C (59-86°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tussin DM Cough & Chest Congestion

NDC 51013-166-08

*Compare to the active ingredients in Robitussin® Maximum Strength Cough Plus Chest Congestion DM

Carton Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1111663	Dextromethorphan/guaiFENesin (Oral Pill)	dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1111663	dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule	PSN	2
1111663	dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51013-166-08	2025-01-30	C162847	48780-1	2cef2736-a98b-d83d-e063-dadaa90ab31f	Tussin DM Cough & Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-166-08	Tussin DM Cough and Chest Congestion	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		2
51013-166-08	Tussin DM Cough and Chest Congestion	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-166	TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	2	Legacy NDC, 2 package rows	20200104_9a94f23b-e109-41ab-8904-572b80709a15.zip

Products#

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

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

Tussin DM Cough and Chest Congestion
dextromethorphan hydrobromide, guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-166	51013-166-08

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
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c30cf25a-f77a-4e43-a143-9676cb5a3707			9a94f23b-e109-41ab-8904-572b80709a15	2020-01-02	Warnings	Exact identifier spl id: c30cf25a-f77a-4e43-a143-9676cb5a3707 spl set id: 9a94f23b-e109-41ab-8904-572b80709a15

Reported adverse events (FAERS/openFDA)#

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