DEXTROMETHORPHAN HBR, GUAIFENESIN

Manufacturer
OPMX LLC | MEDGEL PRIVATE LIMITED
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:10:43

Label at a glance#

ProductDEXTROMETHORPHAN HBR, GUAIFENESIN
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20mg

Guaifenesin 400mg

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

INACTIVE INGREDIENT SECTION

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed – See overdose warning
Do not use for more than 7 days
Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

Children under 12 years of age: do not use

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus)
Helps thin bronchial secretions to make coughs more productive

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:

  • 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 for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

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

OVERDOSAGE SECTION

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTHER SAFETY INFORMATION

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENTREXCILINAPENTREXCILINA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN7
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD7

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-781-02DEXTROMETHORPHAN HBR, GUAIFENESIN20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-781DEXTROMETHORPHAN HBR, GUAIFENESIN CAPSULE, LIQUID FILLED [OPMX LLC]7Current NDC, Legacy NDC, 1 package rows20240406_9a16e7f3-78aa-0b01-e053-2a95a90ab19c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-78169729-781-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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, GUAIFENESINDEXTROMETHORPHAN HBR, GUAIFENESINOPMX LLC9a16e7f3-78aa-0b01-e053-2a95a90ab19c2024-04-05WarningsExact identifier
ndc (package): 69729-781-02
ndc (product): 69729-781
ndc11 (package): 69729078102
spl id: 155b8919-8006-caa9-e063-6394a90a876b
spl set id: 9a16e7f3-78aa-0b01-e053-2a95a90ab19c

Reported adverse events (FAERS/openFDA)#

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