FDA.reportPublic FDA data

GERI-TUSSIN EXPECTORANT

Manufacturer
Atlantic Biologicals Corps
Effective date
2018-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:56:11

Label at a glance#

ProductGERI-TUSSIN EXPECTORANT
Active ingredientGUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

do not take more than 6 doses in any 24-hour period do not exceed recommended dose adults and children 12 years and over 2-4 teaspoonfuls every 4 hours children under 12 years ask a doctor

Storage and handling

• store at room temperature 15º - 30ºC (59º - 86ºF) • protect from freezing • protect from light • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (per teaspoonful = 5mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use if you are hypersensitive to any of the ingredients

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dose
adults and children 12 years and over
2-4 teaspoonfuls every 4 hours
children under 12 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at room temperature 15º - 30ºC (59º - 86ºF)

• protect from freezing

• protect from light

• TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, caramel, FD and C Red 40, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, water

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 17856-0793

NDC: 17856-0793-1 15 mL in a CUP, UNIT-DOSE

NDC: 17856-0793-2 10 mL in a CUP, UNIT-DOSE

NDC: 17856-0793-3 5 mL in a CUP, UNIT-DOSE

GERI-TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 17856-0793-1

image descriptionimage description

NDC 17856-0793-2

image descriptionimage description

NDC 17856-0793-03

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN3
310604guaifenesin 20 MG/ML Oral SolutionSCD3
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
17856-0793-12020-01-31C16284748780-19d75b9d0-e71c-f424-e053-dadaa90a57ce8d9b270c-faeb-4424-92ef-933ae315f459
17856-0793-22020-01-31C16284748780-19d75b9d0-e71c-f424-e053-dadaa90a57ce8d9b270c-faeb-4424-92ef-933ae315f459
17856-0793-32020-01-31C16284748780-19d75b9d0-e71c-f424-e053-dadaa90a57ce8d9b270c-faeb-4424-92ef-933ae315f459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0793-1GERI-TUSSIN EXPECTORANT15 mL in 1 CUP, UNIT-DOSELIQUID153
17856-0793-2GERI-TUSSIN EXPECTORANT10 mL in 1 CUP, UNIT-DOSELIQUID103
17856-0793-3GERI-TUSSIN EXPECTORANT5 mL in 1 CUP, UNIT-DOSELIQUID53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0793GERI-TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 3 package rows20180707_8d9b270c-faeb-4424-92ef-933ae315f459.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-793-16ML - Milliliter57896-793899258c7-65d8-4f43-bbd1-1369fc6937e212013-08-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-079317856-0793-1, 17856-0793-2, 17856-0793-3
57896-793

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARAMELT9D99G2B1RIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
88f25a0f-4619-4be9-8c80-f0195b5b61d48d9b270c-faeb-4424-92ef-933ae315f4592018-06-20WarningsExact identifier
spl id: 88f25a0f-4619-4be9-8c80-f0195b5b61d4
spl set id: 8d9b270c-faeb-4424-92ef-933ae315f459

Reported adverse events (FAERS/openFDA)#

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