TUSSIN DM

Manufacturer: AARNA USA, Inc.
Effective date: 2026-06-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: daily-update
Hydrated at: 2026-07-15 00:33:01

Label at a glance#

ProductTussin DM Regular

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period mL= milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

Storage and handling

Each 10 mL contains: Sodium 10.23 mg store between 20º-25ºC(68º-77ºF). Do not refrigerate.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-225-6999

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant and Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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. tt you do not know tt 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in any 24-hour period
mL= milliliter
this adult product is not intended for use in children under 12 years of age


age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

Each 10 mL contains:Sodium 10.23 mg
store between 20º-25ºC(68º-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water,sodium benzoate, sodium citrate, sucrose,sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

toll-free 1-877-225-6999

Manufactured for:

AARNA USA Inc.

Leland NC, 28451

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12345

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Tussin DM Regular
Dextromethorphan HBr and Guaifenesin
ANHYDROUS CITRIC ACID
GLYCERIN
MENTHOL
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE
SUCRALOSE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82568-0014	82568-0014-4, 82568-0014-8, 82568-0014-6

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
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB

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
Tussin DM Regular	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	5460c809-71c8-3ad6-e063-6294a90a4e4f	2026-06-16	Warnings	Exact identifier ndc (package): 82568-0014-4 ndc (package): 82568-0014-6 ndc (package): 82568-0014-8 ndc (product): 82568-0014 ndc11 (package): 82568001406 ndc11 (package): 82568001404 ndc11 (package): 82568001408 spl id: 5460ca0d-f6b3-423d-e063-6294a90afce7 spl set id: 5460c809-71c8-3ad6-e063-6294a90a4e4f

Reported adverse events (FAERS/openFDA)#

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