FDA.reportPublic FDA data

Guaifenesin Oral Solution, USP

Manufacturer
KESIN PHARMA CORPORATION | Kesin Pharma
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:32

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

take every 4 hours, as needed, or directed by a doctor do not take more than 6 doses in 24 hours do not exceed recommended dose Age Dose adults and children 12 years and over 2 to 4 tespoonfuls every 4 hours children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours children 2 years to under 6 years 1/2 to 1 teaspoonful every 4 hours under 2 years ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. 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

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours, as needed, or directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
AgeDose
adults and children 12 years and over2 to 4 tespoonfuls every 4 hours
children 6 years to under 12 years1 to 2 teaspoonfuls every 4 hours
children 2 years to under 6 years1/2 to 1 teaspoonful every 4 hours
under 2 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
  • do not refrigerate
  • Do not use this product of printed inner seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-833-537-4679

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the owner of registered trademark of Robitussin ®.

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Revision 03/2025

Kesin Pharma LogoKesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-102-16

Guaifenesin Oral Solution, USP

100 mg/5 mL

Expectorant

Grape Flavor

16 fl oz (473 mL)

Guaifenesin 16 oz Bottle LabelGuaifenesin 16 oz Bottle Label

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
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
81033-102-16Guaifenesin473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-102GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION]1Current NDC, 1 package rows20250406_31b8ad0a-3637-03db-e063-6394a90acdc3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-102-05ML - Milliliter81033-102c04493a2-a5df-4be5-86e1-38cd698bbd6312024-03-12
81033-102-10ML - Milliliter81033-102a990cc84-2678-4699-8dca-ec8808a024a412024-04-05
81033-102-16ML - Milliliter81033-1027a1f8916-cb71-4e4c-a447-b4f532f27ea312025-06-13
81033-102-51ML - Milliliter81033-102118824ef-231f-4404-85a9-9e31242703de12024-01-04
81033-102-52ML - Milliliter81033-1020be6c67c-993a-4d6d-9ecc-515e876c5d3912024-01-04

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
81033-10281033-102-16

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
POTASSIUM CITRATE ANHYDROUS86R1NVR0HWIACT
METHYLPARABENA2I8C7HI9TIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SORBITOL506T60A25RIACT
GUAIFENESIN495W7451VQACTIB
CITRIC ACID2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
ndc (package): 81033-102-16
ndc (product): 81033-102
ndc11 (package): 81033010216
spl id: 31b88302-3352-a500-e063-6294a90acce8
spl set id: 31b8ad0a-3637-03db-e063-6394a90acdc3
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
ndc (product): 81033-102

Reported adverse events (FAERS/openFDA)#

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