FDA.reportPublic FDA data

Diabetic Tussin Expectorant

Manufacturer
MEDTECH PRODUCTS INC | Akorn Operating Company LLC (dba Akorn)
Effective date
2022-03-07
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 Expectorant
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

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 - 20 mL (2 - 4 teaspoons) Children under 12 years ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid 
Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

WARNINGS SECTION

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such 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 - 20 mL (2 - 4 teaspoons)
Children under 12 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25°C (68-77°F).
  • keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Rev #0514:00 04/19

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUGAR & ALCOHOL FREE!

Specifically Formulated for Diabetics

Diabetic Tussin®

CHEST CONGESTION

Guaifenesin (Expectorant)

Thins & Loosens Mucus

4 FL OZ (118 mL)

Diagram Description automatically generatedDiagram Description automatically generated

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992212Diabetic Tussin Expectorant 100 MG in 5 mL Oral SolutionPSN3
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN3
992212guaifenesin 20 MG/ML Oral Solution [Diabetic Tussin EX]SBD3
310604guaifenesin 20 MG/ML Oral SolutionSCD3
992212Diabetic Tussin EX 20 MG/ML Oral SolutionSY3
992212Diabetic Tussin Expectorant 100 MG per 5 ML Oral SolutionSY3
992212Diabetic Tussin Mucus Relief 20 MG/ML Oral SolutionSY3
310604guaifenesin 100 MG per 5 ML Oral SolutionSY3
310604guaifenesin 100 MG per 5 ML Oral SyrupSY3
310604guaifenesin 200 MG per 10 ML Oral SolutionSY3
310604guaifenesin 300 MG per 15 ML Oral SolutionSY3
310604guaifenesin 400 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
61787-514-042024-07-30C16284748780-11030e365-5fc2-111a-e063-dadaa90a10e2Diabetic Tussin Expectorant 61787 514
61787-514-042024-01-30C16284748780-11030e365-5fc2-111a-e063-dadaa90a10e2Diabetic Tussin Expectorant 61787 514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61787-514-04Diabetic Tussin Expectorant118 mL in 1 BOTTLELIQUID1183
61787-514-04Diabetic Tussin Expectorant1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61787-514DIABETIC TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [MEDTECH PRODUCTS INC]3Legacy NDC, 2 package rows20220303_d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-514-04ML - Milliliter61787-514d4538812-5eee-4755-9381-e3a0ed7f105712021-03-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61787-51461787-514-04

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
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
CHERRYBUC5I9595WIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
VANILLAQ74T35078HIACT
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
27e059a5-ece3-4fa7-8f12-59ae0c21bdd4d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc2022-03-07WarningsExact identifier
spl id: 27e059a5-ece3-4fa7-8f12-59ae0c21bdd4
spl set id: d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc

Reported adverse events (FAERS/openFDA)#

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