QUALITY CHOICE Long Acting Cough Softgel

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:52

Label at a glance#

ProductQUALITY CHOICE Long Acting Cough Softgel
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 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 older  take 2 softgels every  6 to 8 hours,  as needed  children under  12 years  do not use

Storage and handling

• store at room temperature between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

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

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 can 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 at room temperature between 20°-25°C (68°-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue no.1, FD&C red no. 40, gelatin (bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday - Friday
8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the Active Ingredient in Robitussin® CoughGels®*

Adult

Relieves cough for up to 8 Hours

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING  

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

PRODUCT OF UNITED ARAB EMIRATES

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® CoughGels®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adult cough SoftgelsAdult cough Softgels

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-303-20QUALITY CHOICE Long Acting Cough Softgel20 in 1 BOTTLECAPSULE, LIQUID FILLED201
83324-303-20QUALITY CHOICE Long Acting Cough Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-303QUALITY CHOICE LONG ACTING COUGH SOFTGEL (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 2 package rows20240828_f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c.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
83324-30383324-303-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsExact identifier
ndc (package): 83324-303-20
ndc (product): 83324-303
ndc11 (package): 83324030320
spl id: b9864639-8295-437e-bcba-e7cc9fce1a30
spl set id: f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c

Reported adverse events (FAERS/openFDA)#

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