FDA.reportPublic FDA data

Cough and Cold HBP

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:19:58

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 take more than directed 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 such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, 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

cough persists more than 1 week, tends to recur, or is accompanied by a 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 take more than directed
  • 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

Quality
  +Plus

NDC 50844-689-21

*Compare to active ingredients in Coricidin® HBP COUGH & COLD

COUGH & COLD HBP

Chlorpheniramine maleate
Dextromethorphan HBr

ANTIHISTAMINE • COUGH SUPPRESSANT

For People with High Blood Pressure

• Cough
• Sneezing
• Runny Nose

Decongestant-free

16 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    REV0224B68921

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality plus 44-689
Quality plus 44-689

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN12
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350844689214GTIN-13: 0350844689214
EAN-13: 0350844689214
GTIN-12: 350844689214
UPC-A: 350844689214
GTIN storage (14 digits): 00350844689214		quality-plus-44-689-1.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-689-21Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED212
50844-689-21Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED812

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
50844-68950844-689-21

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. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
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
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRL.N.K. International, Inc.9f2daffc-1904-4d64-9f84-689c88601e062025-12-03WarningsExact identifier
ndc (package): 50844-689-21
ndc (product): 50844-689
ndc11 (package): 50844068921
spl id: eda8099c-cbbf-4aa3-9142-fbb7a700901b
spl set id: 9f2daffc-1904-4d64-9f84-689c88601e06

Reported adverse events (FAERS/openFDA)#

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