FDA.reportPublic FDA data

Diabetic Tussin DM

Manufacturer
MEDTECH PRODUCTS INC | Akorn Operating Company LLC (dba Akorn)
Effective date
2022-03-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:35

Label at a glance#

ProductDiabetic Tussin DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 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 teaspoonfuls) Children under 12 years Ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 200 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

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
Adults10 mL (2 teaspoonfuls)
Children under 12 yearsAsk a doctor

Other information

OTHER SAFETY INFORMATION

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions and comments?

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

SUGAR & ALCOHOL FREE!

Specifically Formulated for Diabetics

Diabetic Tussin® DM

Dextromethorphan HBr 20 mg (Cough Suppressant)

Guaifenesin 200 mg (Expectorant)

COUGH & CHEST CONGESTION

Relieves

  • Mucus
  • Coughs
  • Soothes Throat
  • Chest Congestion

4 Fl. Oz. (118 mL)

SUGAR & ALCOHOL FREE! Specifically Formulated for Diabetics Diabetic Tussin® DM Dextromethorphan HBr 20 mg (Cough Suppressant) Guaifenesin 200 mg (Expectorant) COUGH & CHEST CON...SUGAR & ALCOHOL FREE! Specifically Formulated for Diabetics Diabetic Tussin® DM Dextromethorphan HBr 20 mg (Cough Suppressant) Guaifenesin 200 mg (Expectorant) COUGH & CHEST CON...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61787-513-042024-07-30C16284748780-11030e365-6acd-111a-e063-dadaa90a10e2DiabeticTussin DM 61787-513
61787-513-042024-01-30C16284748780-11030e365-6acd-111a-e063-dadaa90a10e2DiabeticTussin DM 61787-513

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61787-513-04Diabetic Tussin DM1 in 1 BOXLIQUID13
61787-513-04Diabetic Tussin DM118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61787-513DIABETIC TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MEDTECH PRODUCTS INC]3Legacy NDC, 2 package rows20220303_84ad9126-0d42-482d-885c-8a5a0f796de6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-513-04ML - Milliliter61787-513dcacac80-04f0-4633-9dbe-572f800c387d12021-03-02

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61787-51361787-513-04

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
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
CHERRYBUC5I9595WIACT
VANILLAQ74T35078HIACT
ASPARTAMEZ0H242BBR1IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3481758a-0a8d-4f00-a61b-7b7ddf55277884ad9126-0d42-482d-885c-8a5a0f796de62022-03-03WarningsExact identifier
spl id: 3481758a-0a8d-4f00-a61b-7b7ddf552778
spl set id: 84ad9126-0d42-482d-885c-8a5a0f796de6

Reported adverse events (FAERS/openFDA)#

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