Diabetic Tussin DM

Manufacturer
Carilion Materials Management
Effective date
2018-02-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:54:43

Label at a glance#

ProductDiabetic Tussin DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 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 6 years to under 12 years 5 mL (1 teaspoonful) children 2 years to under 6 years 2.5 mL (½ teaspoonful) children under 2 years ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg

Guaifenesin 100 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 6 years to under 12 years5 mL (1 teaspoonful)
children 2 years to under 6 years2.5 mL (½ teaspoonful)
children under 2 yearsask a doctor

Other information

SPL UNCLASSIFIED SECTION

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 1-800-899-3116, 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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 68151-0062

NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE

DIABETIC TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN5
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY5
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY5

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0062-12020-01-31C16284748780-19d75b9d0-699d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0062-1Diabetic Tussin DM5 mL in 1 CUP, UNIT-DOSELIQUID55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0062DIABETIC TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [CARILION MATERIALS MANAGEMENT]5Legacy NDC, 1 package rows20180227_c7e6a5c2-245c-4aa7-adf0-a0baf56ce9ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-062-04ML - Milliliter61787-0622b64d78f-cbd6-4b06-be28-641a9e29fa2712012-07-24

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
68151-006268151-0062-1
61787-062

Ingredients#

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

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

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
357188f7-29c5-41c8-ab4f-0dd04bc9cfdac7e6a5c2-245c-4aa7-adf0-a0baf56ce9ac2018-02-06WarningsExact identifier
spl id: 357188f7-29c5-41c8-ab4f-0dd04bc9cfda
spl set id: c7e6a5c2-245c-4aa7-adf0-a0baf56ce9ac

Reported adverse events (FAERS/openFDA)#

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