FDA.reportPublic FDA data

Guaifenesin Oral Solution 100mg/5mL

Manufacturer
Belleview Biosciences
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:37

Label at a glance#

ProductGuaifenesin 100mg/5mL
Active ingredientGUAIFENESIN
Label structure8 sections

Label contents#

Full prescribing information#

Dosage & Admin

DOSAGE & ADMINISTRATION SECTION

Directions:

■ do not take more than 6 doses in any 24-hour period.

AGEDOSE
Adults & Children 12 years and over2-4 teaspoonfuls every 4 hours
Children 6 years to under 12 years1-2 teaspoonfuls every 4 hours
Children 2 to under 6 years

1/2 - 1 teaspoonfuls every 4 hours

Children Under 2 yearsAsk a Doctor

Warnings

WARNINGS SECTION

Warnings:

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 of breast-feeding, ask a health professional before

use. Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE SECTION

Uses:

■ helps loosen phlegm (mucus) and thin bronchial secretions to make

coughs more productive

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.

OTC - PURPOSE SECTION

Purpose: Expectorant

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL tsp)

Guaifenesin 100 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84447-101 Bulk Label84447-101 Bulk Label

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383335101162GTIN-13: 0383335101162
EAN-13: 0383335101162
GTIN-12: 383335101162
UPC-A: 383335101162
GTIN storage (14 digits): 00383335101162		0fc928a8-1701-ee71-e063-6394a90a6e54.jpg

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-101-01Guaifenesin 100mg/5mL200000 mL in 1 BOTTLE, PLASTICSOLUTION2000002
84447-101-04Guaifenesin 100mg/5mL118 mL in 1 BOTTLE, PLASTICSOLUTION1182
84447-101-08Guaifenesin 100mg/5mL237 mL in 1 BOTTLE, PLASTICSOLUTION2372
84447-101-16Guaifenesin 100mg/5mL473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-101GUAIFENESIN 100MG/5ML (GUAIFENESIN) SOLUTION [BELLEVIEW BIOSCIENCES]24 package rows20241123_1db51cac-13c3-6ee0-e063-6294a90ad4ac.zip

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
84447-10184447-101-16, 84447-101-08, 84447-101-04, 84447-101-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
POTASSIUM CITRATEEE90ONI6FFIACT
METHYLPARABENA2I8C7HI9TIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
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
275e6a88-893a-395d-e063-6394a90a3ff51db51cac-13c3-6ee0-e063-6294a90ad4ac2024-11-20WarningsExact identifier
spl id: 275e6a88-893a-395d-e063-6394a90a3ff5
spl set id: 1db51cac-13c3-6ee0-e063-6294a90ad4ac

Reported adverse events (FAERS/openFDA)#

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