FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Manufacturer
OPMX LLC | KJD Pharma Pvt Ltd
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:01:05

Label at a glance#

ProductDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period measure only with dosing cup provided ml=milliliter this adult product is not intended for use in children under 12 years of age Age Dose Adults and children 12 years and over 5 mL every 4 hours Children under 12 years do not use

Storage and handling

Store at 20°-25°C (68° -77°F).  Do not refrigerate. Retain carton for future reference on full labeling

Label contents#

Full prescribing information#

Active Ingredient (in each 5 mL)                      Purpose

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP 20 mg............. Cough suppressant

Guaifenesin, USP 300 mg............................... Expectorant

OTC - PURPOSE SECTION

Relieves:
• Chest congestion / Mucus
• Cough

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • Do not useif 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

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feedingask 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • ml=milliliter
  • this adult product is not intended for use in children under 12 years of age

Age

Dose

Adults and children 12 years and over

5 mL every 4 hours

Children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 619-600-5632

Tamper evident: Do not use if inner seal under cap is broken or missing.

Exclusively distributed by
OPMX
Chula Vista, CA91910
Phone: 619-600-5632


Manufactured in
FDA Registered Facility
In the USA

PRINCIPAL DISPLAY PANEL PENTREXCILINA ADULT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENTREX ADULTPENTREX ADULT

PRINCIPAL DISPLAY PANEL BROSOLVAN ADULT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BROSOLVAN ADULTBROSOLVAN ADULT

PRINCIPAL DISPLAY PANEL HISTIACIL ADULT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HISTIACIL ADULTHISTIACIL ADULT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1117394dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral SolutionPSN7
1117394dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral SolutionSCD7
1117394dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral SolutionSY7

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-020-042024-04-02C16284748780-11030e365-1e73-111a-e063-dadaa90a10e2Histiacil NF Pentrexicilina NF Brosolvan
69729-020-042024-01-30C16284748780-11030e365-1e73-111a-e063-dadaa90a10e2Histiacil NF Pentrexicilina NF Brosolvan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-020-04DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1187
69729-040-04DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1187
69729-062-04DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN118 mL in 1 BOTTLESYRUP1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-020DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC]7Current NDC, Legacy NDC, 1 package rows20250516_826c2f47-00a6-4060-a7ad-1ef26ccfddd1.zip
69729-040DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC]7Current NDC, Legacy NDC, 1 package rows20250516_826c2f47-00a6-4060-a7ad-1ef26ccfddd1.zip
69729-062DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC]7Current NDC, Legacy NDC, 1 package rows20250516_826c2f47-00a6-4060-a7ad-1ef26ccfddd1.zip

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
69729-06269729-062-04
69729-04069729-040-04
69729-02069729-020-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
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
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINOPMX LLC826c2f47-00a6-4060-a7ad-1ef26ccfddd12025-05-15WarningsExact identifier
ndc (package): 69729-062-04
ndc (package): 69729-020-04
ndc (package): 69729-040-04
ndc (product): 69729-062
ndc (product): 69729-040
ndc (product): 69729-020
ndc11 (package): 69729002004
ndc11 (package): 69729004004
ndc11 (package): 69729006204
spl id: 352f8de3-8fe0-4098-e063-6294a90ace4d
spl set id: 826c2f47-00a6-4060-a7ad-1ef26ccfddd1

Reported adverse events (FAERS/openFDA)#

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