FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan Hydrobromide Syrup

Manufacturer
Method Pharmaceuticals
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:07

Label at a glance#

ProductGuaifenesin and Dextromethorphan Hydrobromide
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation 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-hour period. This adult product is not intended for use in children under 12 years of age adults and children 12 years and over 2 teaspoonfuls (TSP) every 4 hours children 6 to 12 years of age 1 teaspoonful (TSP) every 4 hours children under 6 years DO NOT USE

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial
    irritation
  • 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

  • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days or occurs with fever, rash, or
    headaches that lasts. This could be a sign of a serious condition
  • hypersensitive to any ingredients

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age
adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
children 6 to 12 years of age1 teaspoonful (TSP) every 4 hours
children under 6 yearsDO NOT USE

TAMPER-EVIDENT

OTHER SAFETY INFORMATION

Do not use if seal cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20°-25°C (68°-77°F)
  • each 5 mL contains: sodium 3 mg

Questions

OTC - QUESTIONS SECTION

1-877-250-3427

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Method Pharmaceuticals

NDC 58657-504-08

Guaifenesin and Dextromethorphan Hydrobromide Syrup

100 mg/10 mg/5 mL

Expectorant

Cough Suppressant

Grape Flavor

Non Drowsy • Alcohol Free

FOR AGES 12 AND UP

8 fl. oz. (237 mL)

Manufactured For:

Method Pharmaceuticals, LLC

Southlake, TX 76092 Rev. 02/2024

labellabel

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-504-08Guaifenesin and Dextromethorphan Hydrobromide237 mL in 1 BOTTLE, PLASTICSYRUP2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-504-08ML - Milliliter58657-504797d83ae-ada2-4e8c-ac96-2d0e6213838d12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-50458657-504-08

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
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 40WZB9127XOAIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MENTHOLL7T10EIP3AIACT
SODIUM BENZOATEOJ245FE5EUIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
DEXTROSEIY9XDZ35W2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-04-01full-release2026-06-01 00:12:09

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 and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsExact identifier
ndc (package): 58657-504-08
ndc (product): 58657-504
ndc11 (package): 58657050408
spl id: 41b4eb73-e463-24b0-e063-6394a90a6cc0
spl set id: 1538bf63-d020-3ba2-e063-6294a90aecc5

Reported adverse events (FAERS/openFDA)#

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