FDA.reportPublic FDA data

Adult Cough Relief

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2024-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:14

Label at a glance#

ProductAdult Cough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Dosage and administration

take recommended dosage or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product shake well before using mL=milliliter age  dose   adults and children 12 years and over 10 mL every 6-8 hours not to exceed 4 doses in 24 hours,  children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours  children under 6 years of age  ...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

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 the common cold or inhaled irritants
    • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

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

When using this product,

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, cough comes back, or  occurs by fever, rash or headache that lasts. 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

  • take recommended dosage or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • shake well before using
  • mL=milliliter
age dose 
 adults and children 12 years and over10 mL every 6-8 hours not to exceed 4 doses in 24 hours, 
children 6 to 11 years of age5 mL every 6-8 hours not to exceed 4 doses in 24 hours
 children under 6 years of age do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 3 mg 
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, disodium EDTA, FD&C yellow #6, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Questilons or comments?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough Relief

Cough Suppressant

Dextromethorphan HBr 15 mg

Cough suppressant

For Ages 6 & Over

6-8 hour Relief

Alcohol-Free

Orange Flavor

FL OZ (mL)

Dosing Cup Included

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by CDMA, Inc.

Novi, MI 48375

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Cough Relief
QUALITY CHOICE Cough Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN2
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD2
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY2
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY2

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
83324-134-04Adult Cough Relief1 in 1 BOXLIQUID12
83324-134-04Adult Cough Relief118 mL in 1 BOTTLE, PLASTICLIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-134ADULT COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Current NDC, 2 package rows20240731_6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-134-04ML - Milliliter83324-134dc08b673-c5a5-46c4-ba7e-640bab51888012025-05-14

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-13483324-134-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)L605B5892VIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

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
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
ndc (package): 83324-134-04
ndc (product): 83324-134
ndc11 (package): 83324013404
spl id: 8bae585a-98a5-4e7b-8dab-6ff4c19c04ba
spl set id: 6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c

Reported adverse events (FAERS/openFDA)#

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