OTC Medication Information: Cough and Cold HBP

COUGH AND COLD HBP- chlorpheniramine maleate and dextromethorphan hydrobromide tablet, film coated
Cardinal Health 110, LLC. DBA Leader

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purpose

AntihistamineCough suppressant

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

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.

Ask a doctor before use if you have

  • 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

taking sedatives or tranquilizers.

When using this product

  • 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

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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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

  • 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

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?

1-800-426-9391

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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

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 REV0121A68921

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979

Cardinal Health™

©2022 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal
Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health.
All other marks are the property of their respective owners.

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

Leader 44-689
(click image for full-size original)

Leader 44-689

COUGH AND COLD HBP chlorpheniramine maleate, dextromethorphan hbr tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 27 ALUMINUM LAKE
FD&C YELLOW NO. 6
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 44;689
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0324-1 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70000-0324-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 05/15/2017
Labeler — Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (70000-0324), pack (70000-0324)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (70000-0324)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (70000-0324)

Revised: 09/2023 Cardinal Health 110, LLC. DBA Leader

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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