Tussin DM

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2021-02-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 22:51:47

Label at a glance#

ProductTussin DM cough and chest congestion

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure9 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 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product 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

Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL store at 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 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

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. 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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
measure only with dosing cup provided
keep dosing cup with product
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

Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL
store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4884-4	2024-06-14	C162847	48780-1	ba0f9c33-3b34-a910-e053-dadaa90a0b85	Perrigo Tussin DM Drug Facts
68071-4884-4	2023-01-30	C162847	48780-1	ba0f9c33-3b34-a910-e053-dadaa90a0b85	Perrigo Tussin DM Drug Facts
68071-4884-4	2021-02-17	C162847	48780-1	ba0f9c33-3b34-a910-e053-dadaa90a0b85	Perrigo Tussin DM Drug Facts
68071-4884-4	2021-01-29	C162847	48780-1	ba0f9c33-3b34-a910-e053-dadaa90a0b85	Perrigo Tussin DM Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-0578-26	ML - Milliliter	0113-0578	d3621ed9-cd7c-439e-9c28-dbd7491f8d17	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Tussin DM cough and chest congestion
Dextromethorphan HBr, Guaifenesin
ASPARTAME
BENZOIC ACID
GLYCERIN
MENTHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-4884	68071-4884-4
0113-0578

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPARTAME	Z0H242BBR1	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	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
1ae1b6c2-d5e7-1029-e063-6394a90a5d6a			883f643b-2837-5a3e-e053-2995a90a8ff1	2024-06-14	Warnings	Exact identifier spl set id: 883f643b-2837-5a3e-e053-2995a90a8ff1

Reported adverse events (FAERS/openFDA)#

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