FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY | Medgel Private Limited
Effective date
2023-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:33

Label at a glance#

ProductDEXTROMETHORPHAN HYDROBROMIDE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Dosage and administration

do not take more than 8 softgels 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 take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use

Storage and handling

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 15mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if cough lasts for more than 7 days, comes back, 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 overdose, get medical help orcontact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 8 softgels 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 take 2 capsules every 6 to 8 hours, as needed
  • children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, gelatin, glycerin, sorbitol, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bulk LabelBulk Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN3
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55629-011-012025-01-30C16284748780-1f386c649-a362-0266-e053-dadaa90a7c1a0ffaa7d8-713f-4e4a-beca-2401de17de6f
55629-011-012023-03-25C16284748780-1f386c649-a362-0266-e053-dadaa90a7c1a0ffaa7d8-713f-4e4a-beca-2401de17de6f
55629-011-012023-01-30C16284748780-1f386c649-a362-0266-e053-dadaa90a7c1a0ffaa7d8-713f-4e4a-beca-2401de17de6f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-011-01DEXTROMETHORPHAN HYDROBROMIDE48 in 1 CARTONCAPSULE, LIQUID FILLED483
55629-011-02DEXTROMETHORPHAN HYDROBROMIDE750 in 1 POUCHCAPSULE, LIQUID FILLED7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-011DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]3Legacy NDC, 2 package rows20230326_0ffaa7d8-713f-4e4a-beca-2401de17de6f.zip

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
55629-01155629-011-02, 55629-011-01

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE K30U725QWY32XIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
d67fcfe3-e54b-4450-9db2-756f4e492fbd0ffaa7d8-713f-4e4a-beca-2401de17de6f2023-03-25WarningsExact identifier
spl id: d67fcfe3-e54b-4450-9db2-756f4e492fbd
spl set id: 0ffaa7d8-713f-4e4a-beca-2401de17de6f

Reported adverse events (FAERS/openFDA)#

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