Diabetic Tussin DM Maximum Strength

Manufacturer: Health Care Products | Hi-Tech Pharmacal Co., Inc.
Effective date: 2019-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:02:04

Label at a glance#

ProductDiabetic Tussin DM Maximum Strength

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure9 sections

Indications and uses

• temporarily relieves cough • 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 & children 12 years & over 10 mL (2 teaspoonfuls) children under 12 years of age ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-899-3116

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough
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
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 & children 12 years & over	10 mL (2 teaspoonfuls)
children under 12 years of age	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
store at room temperature 20-25ºC (68-77ºF)
keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, artificial cherry & vanilla flavors, aspartame, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, and purified water. Citric acid may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Rev #064:03 12/11

Package Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61787-064-08

Diabetic Tussin^®

DM MAXIMUM STRENGTH

Cough Suppressant & Expectorant

RELIEVES COUGHS

SOOTHES THROAT

RELIEVES CHEST CONGESTION

Liquid

No Sodium, Dye, Sorbitol, Fructose

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

8 FL OZ (237 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	3
1046631	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral Solution	SCD	3
1046631	dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral Solution	SY	3
1046631	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 10 ML Oral Solution	SY	3

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
61787-064-04	2021-01-29	C162847	48780-1	ba0f9c33-1704-a910-e053-dadaa90a0b85	Drug Facts
61787-064-08	2021-01-29	C162847	48780-1	ba0f9c33-1704-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61787-064-04	Diabetic Tussin DM Maximum Strength	1 in 1 BOX	LIQUID	1	3
61787-064-04	Diabetic Tussin DM Maximum Strength	118 mL in 1 BOTTLE	LIQUID	118	3
61787-064-08	Diabetic Tussin DM Maximum Strength	237 mL in 1 BOTTLE	LIQUID	237	3
61787-064-08	Diabetic Tussin DM Maximum Strength	1 in 1 BOX	LIQUID	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61787-064	DIABETIC TUSSIN DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [HEALTH CARE PRODUCTS]	3	Legacy NDC, 4 package rows	20191218_9708c338-f00e-4fc2-a759-44b65db0860d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-064-04	ML - Milliliter	61787-064	0e28ae95-3344-45fb-b118-ee4c76e5201e	1	2012-07-24
61787-064-08	ML - Milliliter	61787-064	f79601e2-1e22-4c3b-9dc6-f442a2bab310	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61787-064	61787-064-04, 61787-064-08

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
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ASPARTAME	Z0H242BBR1	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 246 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SUSPENSION / ORAL		23 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / DENTAL	0.12 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / SUBLINGUAL		13 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, ORALLY DISINTEGRATING / ORAL		24 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL		111 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates

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
39f7ba09-bc2d-4998-b27e-1549ea325fba			9708c338-f00e-4fc2-a759-44b65db0860d	2019-12-17	Warnings	Exact identifier spl id: 39f7ba09-bc2d-4998-b27e-1549ea325fba spl set id: 9708c338-f00e-4fc2-a759-44b65db0860d

Reported adverse events (FAERS/openFDA)#

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