FDA.reportPublic FDA data

Coricidin HBP Cough and Cold

Manufacturer
A-S Medication Solutions
Effective date
2024-03-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:09:40

Label at a glance#

ProductCoricidin HBP Cough and Cold
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet) Purpose

Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE 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

Do not use to sedate children.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not exceed recommended dose
  • adults and children 12 years and over: take 1 tablet every 6 hours, not more

than 4 tablets in 24 hours

  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

Inactive ingredients 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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5534

NDC: 50090-5534-0 8 TABLET in a BLISTER PACK / 2 in a CARTON

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN8
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD8

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5534-02023-02-07C16284748780-1f386c649-db20-0266-e053-dadaa90a7c1aCoricidin HBP Cough and Cold UI 1614831
50090-5534-02023-01-30C16284748780-1f386c649-db20-0266-e053-dadaa90a7c1aCoricidin HBP Cough and Cold UI 1614831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5534-0Coricidin HBP Cough and Cold8 in 1 BLISTER PACKTABLET88
50090-5534-0Coricidin HBP Cough and Cold2 in 1 CARTONTABLET28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5534CORICIDIN HBP COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240313_ffcae882-0b19-4219-bbee-a175c63d79c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5534-0EA - Each50090-5534a423d8d8-2f41-4341-861f-36be7e0e027e12023-02-06

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
50090-553450090-5534-0
11523-0008

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
ANHYDROUS LACTOSE3SY5LH9PMKIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEBayer HealthCare LLC.b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d2025-12-04WarningsExact identifier
ndc (product): 11523-0008
Coricidin HBP Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDEA-S Medication Solutionsffcae882-0b19-4219-bbee-a175c63d79c82024-03-11WarningsExact identifier
ndc (package): 50090-5534-0
ndc (product): 50090-5534
ndc11 (package): 50090553400
spl id: 0b630cb7-22eb-4536-a839-9d05e0222017
spl set id: ffcae882-0b19-4219-bbee-a175c63d79c8

Reported adverse events (FAERS/openFDA)#

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