Guaifenesin 400 mg and Dextromethorphan Hydrobromide 20 mg Softgelatin Capsules

Manufacturer
Softgel Healthcare Pvt Ltd
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:55:05

Label at a glance#

ProductGuaifenesin,Dextromethorphan Hbr
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Label contents#

Full prescribing information#

Active ingredient (in each soft gelatin capsule)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP 400mg

Dextromethorphan HBr USP 20mg

OTC - PURPOSE SECTION

Purposes

Expectorant

Cough suppressant

INDICATIONS & USAGE SECTION

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 rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • do not use for more than 7 days

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
  • Keep in dry place and do not expose to heat

INACTIVE INGREDIENT SECTION

Inactive ingredients

gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN4
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0759-3Guaifenesin,Dextromethorphan Hbr2000 in 1 POUCHCAPSULE, LIQUID FILLED20004
35916-0759-3Guaifenesin,Dextromethorphan Hbr2 in 1 BOXCAPSULE, LIQUID FILLED24
35916-0759-4Guaifenesin,Dextromethorphan Hbr2 in 1 BOXCAPSULE, LIQUID FILLED24
35916-0759-4Guaifenesin,Dextromethorphan Hbr1500 in 1 BAGCAPSULE, LIQUID FILLED15004

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-075935916-0759-3, 35916-0759-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-01-14monthly-update2026-06-03 17:52:57

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,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
ndc (package): 35916-0759-3
ndc (package): 35916-0759-4
ndc (product): 35916-0759
ndc11 (package): 35916075903
ndc11 (package): 35916075904
spl id: 50032ae7-88ff-59ad-e063-6394a90a45c2
spl set id: 3e5d978f-cc70-60a5-e063-6394a90a67d3

Reported adverse events (FAERS/openFDA)#

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