FDA.reportPublic FDA data

CVS Health Chest Congestion and Cough HBP SOFTGEL

Manufacturer
CVS Pharmacy, Inc
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:47

Label at a glance#

ProductCVS Health Chest Congestion and Cough HBP SOFTGEL
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

• do not exceed recommended dose • adults and children 12 years and over: 1 or 2 softgels every 4 hours. Do not take more than 12 softgels in 24 hours or as directed by a doctor • children under 12 years of age: do not use

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan hydrobromide 10 mg
Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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 • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age

Ask a doctor before use if you have
• cough that occurs with excessive phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with 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 right away. Abuse of this product can lead to serious injury.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed recommended dose
• adults and children 12 years and over: 1 or 2 softgels every 4 hours. Do not take more than 12 softgels in 24 hours or as directed by a doctor
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-SHOP-CVS

SPL UNCLASSIFIED SECTION

Compare to the active ingredients in Coricidin® HBP Chest Congestion & Cough*

†Decongestant Free

For People with High Blood Pressure†

Relieves:
• Chest congestion
• Cough

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP Chest Congestion and Cough.

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com®

Product of India

100% money back guaranteed.
CVS.com/returnpolicy

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS-830CVS-830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN2
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-830-02CVS Health Chest Congestion and Cough HBP SOFTGEL2 in 1 CARTONCAPSULE, LIQUID FILLED22
51316-830-02CVS Health Chest Congestion and Cough HBP SOFTGEL10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-830CVS HEALTH CHEST CONGESTION AND COUGH HBP SOFTGEL (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]2Current NDC, 2 package rows20250117_2741ba44-1cc7-1812-e063-6394a90a8faa.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-83051316-830-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
CVS Health Chest Congestion and Cough HBP SOFTGELDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy, Inc2741ba44-1cc7-1812-e063-6394a90a8faa2025-01-14WarningsExact identifier
ndc (package): 51316-830-02
ndc (product): 51316-830
ndc11 (package): 51316083002
spl id: 7c0d96a4-0969-424b-a720-b31b190c832b
spl set id: 2741ba44-1cc7-1812-e063-6394a90a8faa

Reported adverse events (FAERS/openFDA)#

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