Dextromethorphan Hydrobromide 10 mg and Guaifenesin 200 mg Softgelatin Capsules

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:53

Label at a glance#

ProductDextromethorphan Hbr,Guaifenesin
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Label contents#

Full prescribing information#

Active ingredient (in each soft gelatin capsule)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP 10mg

Guaifenesin USP 200mg

OTC - PURPOSE SECTION

Purposes

Cough suppresent

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

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

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

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.

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 overdose, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bulk labelbulk label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN2
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD2

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
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
35916-0760-1Dextromethorphan Hbr,Guaifenesin1000 in 1 BAGCAPSULE, LIQUID FILLED10002

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
35916-076035916-0760-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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,GUAIFENESINSOFTGEL HEALTHCARE PRIVATE LIMITED2fbbfc7c-81a9-b647-e063-6394a90a55ac2026-01-27WarningsExact identifier
ndc (package): 35916-0760-1
ndc (product): 35916-0760
ndc11 (package): 35916076001
spl id: 47b53021-eb30-c736-e063-6294a90ae369
spl set id: 2fbbfc7c-81a9-b647-e063-6394a90a55ac

Reported adverse events (FAERS/openFDA)#

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