Leader 44-689

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Dextromethorphan (30 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 44;689 Shape: round Color: red Size: 9 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-05-15

Medication Information

Purpose

Antihistamine

Cough suppressant

Description

Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg

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

Directions

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

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.

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

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

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

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

CardinalHealth™

©2024 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

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

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,

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.

Active Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

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 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

taking sedatives or tranquilizers.

Structured Label Content

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

Purpose

Antihistamine

Cough suppressant

Directions

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

Do Not Use (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.

Other Information (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 (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? (Questions or comments?)

1-800-426-9391

Principal Display Panel (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

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

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

CardinalHealth™

©2024 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

When Using This Product (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 (Stop use and ask a doctor if)

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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Ask A Doctor Before Use If You Have (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 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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6 ALUMINUM LAKE", "unii": "GYP6Z2JR6Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine Cough suppressant", "Directions": "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", "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.", "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", "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 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 CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Cardinal Health™ ©2024 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", "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": "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,": "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.", "Active ingredients (in each tablet)": "Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg", "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 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": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information