FDA.reportPublic FDA data

COUGH RELIEF

Manufacturer
YET HEALTH GROUP LLC
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:36

Label at a glance#

ProductCOUGH RELIEF 15 MG
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient(in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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

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

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.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

call 1-844-735-0202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL (PDP)_Cough Relief_Dex HB5 15mg_150ct01b LBL (PDP)_Cough Relief_Dex HB5 15mg_150ct

01b LBL (DF1)_Cough Relief_Dex HB5 15mg01b LBL (DF1)_Cough Relief_Dex HB5 15mg

01b LBL (DF2)_Cough Relief_Dex HB5 15mg01b LBL (DF2)_Cough Relief_Dex HB5 15mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN5
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81179-015-00COUGH RELIEF15 MG150 in 1 BOTTLECAPSULE, LIQUID FILLED1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81179-015COUGH RELIEF 15 MG (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [YET HEALTH GROUP LLC]5Legacy NDC, 1 package rows20240104_f4f4c498-42d7-4cc5-8fd2-4f6837a3f57b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81179-01581179-015-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
0e129a45-40d9-b056-e063-6394a90adeb4f4f4c498-42d7-4cc5-8fd2-4f6837a3f57b2024-01-03WarningsExact identifier
spl id: 0e129a45-40d9-b056-e063-6394a90adeb4
spl set id: f4f4c498-42d7-4cc5-8fd2-4f6837a3f57b

Reported adverse events (FAERS/openFDA)#

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