FDA.reportPublic FDA data

Dextromethorphan HBr and Guaifenesin Oral Solution

Manufacturer
KESIN PHARMA CORPORATION
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:02

Label at a glance#

ProductDextromethorphan HBr and Guaifenesin Oral Solution
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

DIRECTIONS Follow dosage table below or use as directed by a physician Do not take more than 6 doses in any 24-hour period Age Dose adults and children 12 years and over 10mL (2 teaspoonful) every 4 hours children 6 to under 12 years of age 5mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor

Storage and handling

Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

Label contents#

Full prescribing information#

Dextromethorphan HBr and Guaifenesin Oral Solution 5 and 10 mL

OTC - PURPOSE SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DM Guaifenesin
Non-Narcotic, Sugar, Dye and Alcohol Free
Cough Suppressant/Expectorant

DESCRIPTION

DESCRIPTION SECTION

Each 5 mL (1 teaspoonful) contains:
Dextromethorphan Hydrobromide 10 mg
Guaifenesin 100 mg
Each 10 mL (2 teaspoonfuls) contains:
Dextromethorphan Hydrobromide 20 mg
Guaifenesin 200 mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: citric acid, grape flavor, methylparaben, monoammonium glycrrhizate, potassium citrate, propylene glycol, propylparaban,purified water, sorbitol, sucralose.

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS

WARNINGS SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

  • 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.
  • you are hypersensitive to any of the ingredients.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

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.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA)

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Follow dosage table below or use as directed by a
physician

  • Do not take more than 6 doses in any 24-hour period
AgeDose
adults and children 12 years and over10mL (2 teaspoonful) every 4 hours
children 6 to under 12 years of age5mL (1 teaspoonful) every 4 hours
children 2 to under 6 years of age2.5mL (1/2 teaspoonful) every 4 hours
children under 2 yearsconsult a doctor

HOW SUPPLIED

HOW SUPPLIED SECTION

Dextromethorphan hydrobromide and Guaifenesin is a clear, grape flavor solution supplied in the following oral dosage forms:
5 mL unit dose cup:
NDC 81033-103-05
Case containing 100 units dose cups of 5 mL:
NDC 81033-103-50

10 mL unit dose cups:
NDC 81033-103-10
Case containing 100 unit dose cups of 10 mL:
NDC 81033-103-51

STORAGE

STORAGE AND HANDLING SECTION

Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS
Call 1-833-537-4679

Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective 10/2024
Revision 03

Kesin Pharma LogoKesin Pharma Logo

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-103-05

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

NDC 81033-104-05NDC 81033-104-05

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-103-10

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 20mg/200mg per 10mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

NDC 81033-104-05NDC 81033-104-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-103-05Dextromethorphan HBr and Guaifenesin Oral Solution5 mL in 1 CUP, UNIT-DOSELIQUID53
81033-103-10Dextromethorphan HBr and Guaifenesin Oral Solution10 mL in 1 CUP, UNIT-DOSELIQUID103
81033-103-50Dextromethorphan HBr and Guaifenesin Oral Solution100 in 1 CASELIQUID1003
81033-103-51Dextromethorphan HBr and Guaifenesin Oral Solution100 in 1 CASELIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-103DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION LIQUID [KESIN PHARMA CORPORATION]3Current NDC, 4 package rows20250131_284eae44-81bc-400c-e063-6394a90af446.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-103-05ML - Milliliter81033-10305022df2-becf-472c-847f-e6b263c0f25912025-01-14
81033-103-10ML - Milliliter81033-103caeafea8-7b93-4c06-ada0-124690d9531b12025-01-14
81033-103-50ML - Milliliter81033-1030e79ce48-2721-4f2a-8547-f57a93faf90d12025-01-14
81033-103-51ML - Milliliter81033-103d784e62e-43c5-47bb-8317-3233326558d312025-01-14

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-10381033-103-05, 81033-103-50, 81033-103-10, 81033-103-51
84447-102

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
METHYLPARABENA2I8C7HI9TIACT
GUAIFENESIN495W7451VQACTIB
SORBITOL506T60A25RIACT
POTASSIUM CITRATEEE90ONI6FFIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT

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
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
ndc (package): 81033-103-50
ndc (package): 81033-103-51
ndc (package): 81033-103-10
ndc (package): 81033-103-05
ndc (product): 81033-103
ndc11 (package): 81033010351
ndc11 (package): 81033010310
ndc11 (package): 81033010350
ndc11 (package): 81033010305
spl id: 2cee75e1-ee97-6129-e063-6394a90a03dd
spl set id: 284eae44-81bc-400c-e063-6394a90af446

Reported adverse events (FAERS/openFDA)#

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