FDA.reportPublic FDA data

Diabetic Tussin Expectorant

Manufacturer
Central Texas Community Health Centers
Effective date
2017-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:13

Label at a glance#

ProductDiabetic Tussin Expectorant
Active ingredientGUAIFENESIN
Label structure9 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 & children 12 years and over 10 mL - 20 mL (2 - 4 teaspoonfuls) children 6 years to under 12 years 5 mL - 10 mL (1 - 2 teaspoonfuls) children 2 years to under 6 years 2.5 mL - 5 mL (½ - 1 teaspoonful) children under 2 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 100 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
adults & children 12 years and over 10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • 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 1-800-899-3116, 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 #063:05 10/11

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

City of Austin Dept of Health

GUAIFENESIN
118ml

Date:

Name:
Dr.

TAKE AS DIRECTED.

1/1/01

123456

GUAIFENESIN 118ml NDC 76413-335-01

Batch: 123456
Lot: 123456
Exp: 1/1/01

AKORN

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
992212Diabetic Tussin Expectorant 100 MG in 5 mL Oral SolutionPSN1
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
992212guaifenesin 20 MG/ML Oral Solution [Diabetic Tussin EX]SBD1
310604guaifenesin 20 MG/ML Oral SolutionSCD1
992212Diabetic Tussin EX 20 MG/ML Oral SolutionSY1
992212Diabetic Tussin Expectorant 100 MG per 5 ML Oral SolutionSY1
992212Diabetic Tussin Mucus Relief 20 MG/ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
76413-335-012020-01-31C16284748780-19d75b9d0-340f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-335-01Diabetic Tussin Expectorant118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-335DIABETIC TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20170817_18f4c0c4-4448-470c-bd82-8d6cd3f8cd71.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-063-04ML - Milliliter61787-063471a5c43-e04c-4129-9e98-8431db07940612012-07-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-33576413-335-01
61787-063

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

Source Document#

Source XML · Source PDF

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
494c896e-9a61-4e4a-b301-c81e97ba7bd718f4c0c4-4448-470c-bd82-8d6cd3f8cd712017-08-15WarningsExact identifier
spl id: 494c896e-9a61-4e4a-b301-c81e97ba7bd7
spl set id: 18f4c0c4-4448-470c-bd82-8d6cd3f8cd71

Reported adverse events (FAERS/openFDA)#

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