Diabetic Tussin DM Maximum Strength

Manufacturer: MEDTECH PRODUCTS INC
Effective date: 2025-08-08
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:09:31

Label at a glance#

ProductDiabetic Tussin DM Maximum Strength

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure10 sections

Indications and uses

temporarily relieves cough caused by the common cold or inhaled irritants. helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.

Dosage and administration

take every 4 hours do not exceed 6 doses in 24 hours Adults 10 mL (2 teaspoons) Children under 12 years ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-579-8327

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan hydrobromide 20 mg

Guaifenesin 400 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough caused by the common cold or inhaled irritants.
helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.

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 two 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

a cough that occurs with too much phlegm (mucus)
a chronic cough that lasts or 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 occurs with fever, rash, or headache that lasts as 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.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 hours
do not exceed 6 doses in 24 hours

Adults	10 mL (2 teaspoons)
Children under 12 years	ask a doctor

Other information

OTHER SAFETY INFORMATION

store at room temperature 20-25ºC (68-77ºF)
keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial raspberry flavor, citric acid, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, sucralose, water.

Questions

OTC - QUESTIONS SECTION

Call 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

Package Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetic Tussin®

MAXIMUM STRENGTH

COUGH & CHEST CONGESTION

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

4 FL OZ (118 mL)

Package Principal Display Panel Diabetic Tussin® MAXIMUM STRENGTH COUGH & CHEST CONGESTION DM Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) 4 FL OZ (118 mL)

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1046631	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 10 mL Oral Solution	PSN	5
1046631	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral Solution	SCD	5
1046631	dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral Solution	SY	5
1046631	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 10 ML Oral Solution	SY	5

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61787-515-04	2024-01-30	C162847	48780-1	1030e365-31ea-111a-e063-dadaa90a10e2	DiabeticTussin DM Max Strength 61787-515
61787-515-08	2024-01-30	C162847	48780-1	1030e365-31ea-111a-e063-dadaa90a10e2	DiabeticTussin DM Max Strength 61787-515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61787-515-04	Diabetic Tussin DM Maximum Strength	1 in 1 BOX	LIQUID	1	5
61787-515-04	Diabetic Tussin DM Maximum Strength	118 mL in 1 BOTTLE	LIQUID	118	5
61787-515-08	Diabetic Tussin DM Maximum Strength	237 mL in 1 BOTTLE	LIQUID	237	5
61787-515-08	Diabetic Tussin DM Maximum Strength	1 in 1 BOX	LIQUID	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-515-04	ML - Milliliter	61787-515	05bf2819-f180-4d08-a680-36c26afd23e5	1	2022-09-12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Diabetic Tussin DM Maximum Strength
Dextromethorphan Hydrobromide and Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
ACESULFAME POTASSIUM
HYPROMELLOSE, UNSPECIFIED
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM SORBATE
RASPBERRY
SUCRALOSE
WATER
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61787-515	61787-515-04, 61787-515-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
RASPBERRY	4N14V5R27W	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
WATER	059QF0KO0R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	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
Diabetic Tussin DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	MEDTECH PRODUCTS INC	a10a3b33-7503-4334-8ed7-2bb881df4327	2025-08-08	Warnings	Exact identifier ndc (package): 61787-515-04 ndc (package): 61787-515-08 ndc (product): 61787-515 ndc11 (package): 61787051508 ndc11 (package): 61787051504 spl id: e60166fa-5c2e-4449-9633-97607116cbe5 spl set id: a10a3b33-7503-4334-8ed7-2bb881df4327

Reported adverse events (FAERS/openFDA)#

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