Leader 44-689

Label at a glance#

Contacts and useful links#

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

LEADER™

NDC 70000-0324-1

Cough
& Cold HBP

Chlorpheniramine Maleate, 4 mg
Dextromethorphan HBr, 30 mg
Antihistamine | Cough Suppressant

Relieves:
Cough, Runny Nose,
Sneezing

For People with High
Blood Pressure

Decongestant-Free

16 TABLETS

Actual Size

COMPARE TO
CORICIDIN® HBP
COUGH & COLD
active ingredients*

100% Money Back Guarantee

Related RxNorm Concepts#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Billing Units#

Products#

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

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

• Cough and Cold HBP
• Chlorpheniramine maleate, Dextromethorphan HBr
• CHLORPHENIRAMINE MALEATE
• CHLORPHENIRAMINE
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• CROSCARMELLOSE SODIUM
• D&C RED NO. 27 ALUMINUM LAKE
• FD&C YELLOW NO. 6 ALUMINUM LAKE
• ANHYDROUS LACTOSE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POLYVINYL ALCOHOL, UNSPECIFIED
• SILICON DIOXIDE
• STEARIC ACID
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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.

Reported adverse events (FAERS/openFDA)#

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