FDA.reportPublic FDA data

Cough Relief

Manufacturer
Advanced Rx LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:48

Label at a glance#

ProductCough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure14 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 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 older  take 2 softgels every 6 to 8 hours, as needed  children under 12 years  do not use

Storage and handling

• store between  20° and 25°C (68°–77°F) • avoid excessive heat above 40°C (104°F) • protect from light • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 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 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) 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 older take 2 softgels every 6 to 8 hours, as needed
 children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

• store between  20° and 25°C (68°–77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.

Questions?

OTC - QUESTIONS SECTION

Call  1-800-630-8895

Distributed by: 

SPL UNCLASSIFIED SECTION

Advanced Rx LLC

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-311-06

Cough Relief

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSN1
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCD1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-311-06Cough Relief60 in 1 BOTTLECAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-311COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [ADVANCED RX LLC]1Current NDC, 1 package rows20250117_297e10e3-e740-4434-91a2-2e5c54985d33.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-31180513-311-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
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
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsExact identifier
ndc (package): 80513-311-06
ndc (product): 80513-311
ndc11 (package): 80513031106
spl id: 2bd504ed-3944-e6ce-e063-6294a90aa3de
spl set id: 297e10e3-e740-4434-91a2-2e5c54985d33

Reported adverse events (FAERS/openFDA)#

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