FDA.reportPublic FDA data

Cough and Cold HBP

Manufacturer
Cardinal Health | LNK International, Inc.
Effective date
2017-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:06:26

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. Do not take 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with excessive phlegm (mucus)
  • 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • adults and children 12 years and over: 1 tablet every 6 hours. Do not take 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, black iron oxide, calcium carbonate, carnauba wax, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0139-1

LEADER ™

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

Relieves
Cough, Runny Nose
Sneezing

For People with High
Blood Pressure

Decongestant-free

16 TABLETS

COMPARE TO CORICIDIN® HBP COUGH & COLD
active ingredients*
100% Money Back Guarantee

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

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com  1-800-200-6313
Essential to Care™ since 1979

©2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

All LEADER™ Brand Products Have a 100% Money Back Guarantee
Return to place of purchase if not satisfied.

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Leader 44-411Leader 44-411

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295129670GTIN-13: 0096295129670
EAN-13: 0096295129670
GTIN-12: 096295129670
UPC-A: 096295129670
GTIN storage (14 digits): 00096295129670		leader-44-411-delisted-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-013970000-0139-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACACIA5C5403N26OIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT

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
8b4d3fe6-49a8-497c-9d7b-8dee280e4237e5029d35-6ded-47ad-be02-68880d6091a62017-12-19WarningsExact identifier
spl id: 8b4d3fe6-49a8-497c-9d7b-8dee280e4237
spl set id: e5029d35-6ded-47ad-be02-68880d6091a6

Reported adverse events (FAERS/openFDA)#

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