FDA.reportPublic FDA data

Cough and Cold HBP

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC | LNK International, Inc.
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:19:52

Label at a glance#

ProductCough and Cold HBP
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold

Dosage and administration

do not exceed recommended dose adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours children under 12 years: do not use

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine
Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves runny nose and sneezing due to the common cold

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

  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • glaucoma
  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

persistent cough lasts for more than one week, tends to recur, 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide


Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC®
QUALITY
CHOICE

NDC 63868-179-16

*Compare to the active ingredients in CORICIDIN® HBP Cough & Cold

Cough &
Cold HBP
Chlorpheniramine Maleate | Antihistamine
Dextromethorphan HBr | Cough Suppressant

For People with High Blood Pressure
Decongestant-Free

Temporarily Relieves:
Cough
Runny Nose
Sneezing

24 Tablets

Actual Size

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

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Coricidin® HBP Cough & Cold.

50844  REV0121A68908

Distributed by C.D.M.A., Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

PARENTS:
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Quality Choice 44-689
Quality Choice 44-689

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN11
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-179-01Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED811
63868-179-01Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED211
63868-179-16Cough and Cold HBP3 in 1 CARTONTABLET, FILM COATED311
63868-179-16Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-179COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]11Legacy NDC, 4 package rows20240921_320152b8-17ef-40c0-8e4b-cd8f846ae6f5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-179-01EA - Each63868-179ddafb0f3-b5b8-4600-9ac3-cd38c854fb7612018-03-08
63868-179-16EA - Each63868-17981cd7b50-3eda-4121-acf8-d362e792d16612018-03-08

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-17963868-179-01, 63868-179-16

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
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
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
7392298f-484b-4bb9-86f2-807e8d9e3d77320152b8-17ef-40c0-8e4b-cd8f846ae6f52024-09-19WarningsExact identifier
spl id: 7392298f-484b-4bb9-86f2-807e8d9e3d77
spl set id: 320152b8-17ef-40c0-8e4b-cd8f846ae6f5

Reported adverse events (FAERS/openFDA)#

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