FDA.reportPublic FDA data

Geri-Tussin

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:27

Label at a glance#

ProductGeri-Tussin
Active ingredientGUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each 5 mL teaspoonful

Guaifenesin - 100 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

Do not use

  • if you ever had an allergic reaction to any of the ingredients in this product

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

OTC - QUESTIONS SECTION

Questions or comments? 1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179   

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2
310604guaifenesin 20 MG/ML Oral SolutionSCD2
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2

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
17856-0693-12023-01-30C16284748780-1f386c64a-106a-0266-e053-dadaa90a7c1aa307a54c-2861-4027-bec4-da8a984d211e
17856-0693-22023-01-30C16284748780-1f386c64a-106a-0266-e053-dadaa90a7c1aa307a54c-2861-4027-bec4-da8a984d211e
17856-0693-32023-01-30C16284748780-1f386c64a-106a-0266-e053-dadaa90a7c1aa307a54c-2861-4027-bec4-da8a984d211e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0693-1Geri-Tussin10 mL in 1 CUP, UNIT-DOSELIQUID102
17856-0693-1Geri-Tussin72 in 1 BOX, UNIT-DOSELIQUID722
17856-0693-2Geri-Tussin50 in 1 BOX, UNIT-DOSELIQUID502
17856-0693-2Geri-Tussin15 mL in 1 CUP, UNIT-DOSELIQUID152
17856-0693-3Geri-Tussin72 in 1 BOX, UNIT-DOSELIQUID722
17856-0693-3Geri-Tussin5 mL in 1 CUP, UNIT-DOSELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0693GERI-TUSSIN (GUAIFENESIN) LIQUID [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 6 package rows20210128_a307a54c-2861-4027-bec4-da8a984d211e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-693-04ML - Milliliter57896-6937f25273f-d1fc-439d-af72-925bd830bb4a12024-07-12
57896-693-08ML - Milliliter57896-693b5c35bb9-0318-4e23-b8fd-dff274ac9d7012026-01-08
57896-693-16ML - Milliliter57896-6936f03e183-fd4e-458d-b2ab-ebe17daac28b12019-09-05

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
17856-069317856-0693-1, 17856-0693-2, 17856-0693-3
57896-693

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
FD&C RED NO. 40WZB9127XOAIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp65545ca3-4e93-4b59-9e17-4742e086e8e72025-12-31WarningsExact identifier
ndc (product): 57896-693
3326eecf-db1f-4f1d-b0b1-5eb7065841b6a307a54c-2861-4027-bec4-da8a984d211e2021-01-26WarningsExact identifier
spl id: 3326eecf-db1f-4f1d-b0b1-5eb7065841b6
spl set id: a307a54c-2861-4027-bec4-da8a984d211e

Reported adverse events (FAERS/openFDA)#

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