Cough Relief

Manufacturer
Topco Associates LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:35

Label at a glance#

ProductCough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure11 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 age      dose adults and children 12 years and over      take 2 softgels every 6 to 8 hours, as needed children under 12 years      do not use

Storage and handling

store at room temperature 15-30°C (59-86°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 15 mg

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 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

  • 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 a 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact 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

age

     dose

adults and children 12 years and over

     take 2 softgels every 6 to 8 hours, as needed

children under 12 years

     do not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-888-423-0139

PRINCIPAL DISPLAY PANEL - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Cough Relief

Dextromethorphan HBr, USP 15 mg 20 SOFTGELS

NDC 36800-415-15

*Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®

Carton Label FrontCarton Label Front

Carton Label BackCarton Label Back

PRINCIPAL DISPLAY PANEL - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Cough Relief

Dextromethorphan HBr, USP 15 mg 20 SOFTGELS

NDC 36800-415-15

Bottle LabelBottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN2
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD2

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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-415-152025-01-30C16284748780-12cef2736-aa8a-d83d-e063-dadaa90ab31fCough Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-415-15Cough Relief20 in 1 BOTTLECAPSULE, LIQUID FILLED202
36800-415-15Cough Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-415COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20191122_4a35e6bb-9d66-496a-b687-cd09c93306a0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-41536800-415-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
12c6e440-72d2-4bfc-b45d-60d28efa68a34a35e6bb-9d66-496a-b687-cd09c93306a02019-11-21WarningsExact identifier
spl id: 12c6e440-72d2-4bfc-b45d-60d28efa68a3
spl set id: 4a35e6bb-9d66-496a-b687-cd09c93306a0

Reported adverse events (FAERS/openFDA)#

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