FDA.reportPublic FDA data

Guaifenesin STRAWBERRY-BANANA FLAVOR

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:23

Label at a glance#

ProductGuaifenesin STRAWBERRY-BANANA FLAVOR
Active ingredientGUAIFENESIN
Label structure8 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 hours period  age  dose  Adults and Children 12 years of age and over: Children under 12 years of age:  Take 2-4 teaspoonful (5mL) every 4 hours Consult a physician

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin,USP 100 mg (in each 5ml tsp)

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 take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if■ cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than 6 doses in any 24 hours period
 age dose

 Adults and Children 12 years of age and over:

Children under 12 years of age:

 Take 2-4 teaspoonful (5mL) every 4 hours

Consult a physician

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature ■ 15°-30°C (59°-86°F)
  • TAMPER-EVIDENT: Do not use if seal under cap is torn, broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1
310604guaifenesin 20 MG/ML Oral SolutionSCD1
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71800-059-19Guaifenesin STRAWBERRY-BANANA FLAVOR119 mL in 1 TUBELIQUID1191

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-059-19ML - Milliliter71800-059d3fa3ffd-d057-44a7-b7b8-f8d657a3803c12026-04-20

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-05971800-059-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
STRAWBERRY4J2TY8Y81VIACT
GUAIFENESIN495W7451VQACTIB

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
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
ndc (package): 71800-059-19
ndc (product): 71800-059
ndc11 (package): 71800005919
spl id: 37de006a-e717-a4e5-e063-6394a90abd8b
spl set id: 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16

Reported adverse events (FAERS/openFDA)#

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