Leader 44-030

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-16

Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions

do not take more than directed
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
adults and children 12 years and over: 20 mL in dosing cup provided every 4 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

each 20 mL contains: sodium 16 mg
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

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, and carboxymethylcellulose sodium, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER♥_™

NDC 70000-0628-1

Maximum Strength

Tussin DM

Cough & Chest

Congestion DM

Dextromethorphan HBr

Guaifenesin

Cough Suppressant

Expectorant

Oral Solution

Menthol-Berry

Flavor

Ages 12 Years

and Over

Controls Cough

Relieves Chest

Congestion

Thins &

Loosens

Mucus

COMPARE TO

ROBITUSSIN^®

MAXIMUM STRENGTH

COUGH + CHEST

CONGESTION DM

active ingredients*

100% Money Back Guarantee

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Haleon US Holdings

LLC, owner of the registered trademark Robitussin® Maximum Strength

Cough+Chest Congestion DM.

50844 REV0325B03036

©2025 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.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

√ All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

CLOSE TIGHTLY

TO OPEN

PUSH DOWN & TURN

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Leader 44-030

Stop Use and Ask A Doctor If

cough persists more than 7 days, 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 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Purpose

Cough suppressant

Expectorant

Directions

do not take more than directed
do not take more than 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
adults and children 12 years and over: 20 mL in dosing cup provided every 4 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)

each 20 mL contains: sodium 16 mg
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 ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, and carboxymethylcellulose sodium, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

LEADER♥_™

NDC 70000-0628-1

Maximum Strength

Tussin DM

Cough & Chest

Congestion DM

Dextromethorphan HBr

Guaifenesin

Cough Suppressant

Expectorant

Oral Solution

Menthol-Berry

Flavor

Ages 12 Years

and Over

Controls Cough

Relieves Chest

Congestion

Thins &

Loosens

Mucus

COMPARE TO

ROBITUSSIN^®

MAXIMUM STRENGTH

COUGH + CHEST

CONGESTION DM

active ingredients*

100% Money Back Guarantee

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Haleon US Holdings

LLC, owner of the registered trademark Robitussin® Maximum Strength

Cough+Chest Congestion DM.

50844 REV0325B03036

©2025 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.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

√ All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

CLOSE TIGHTLY

TO OPEN

PUSH DOWN & TURN

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Leader 44-030

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough persists more than 7 days, 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 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

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

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "Purpose": "Cough suppressant Expectorant", "Directions": "do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided adults and children 12 years and over: 20 mL in dosing cup provided every 4 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": "each 20 mL contains: sodium 16 mg 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": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, and carboxymethylcellulose sodium, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "LEADER♥ ™ NDC 70000-0628-1 Maximum Strength Tussin DM Cough & Chest Congestion DM Dextromethorphan HBr Guaifenesin Cough Suppressant Expectorant Oral Solution Menthol-Berry Flavor Ages 12 Years and Over Controls Cough Relieves Chest Congestion Thins & Loosens Mucus COMPARE TO ROBITUSSIN ® MAXIMUM STRENGTH COUGH + CHEST CONGESTION DM active ingredients* 100% Money Back Guarantee 4 FL OZ (118 mL) TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Haleon US Holdings LLC, owner of the registered trademark Robitussin® Maximum Strength Cough+Chest Congestion DM. 50844 REV0325B03036 ©2025 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. Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 √ All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. CLOSE TIGHTLY TO OPEN PUSH DOWN & TURN PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Leader 44-030", "Stop use and ask a doctor if": "cough persists more than 7 days, 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 20 mL)": "Dextromethorphan HBr 20 mg Guaifenesin 400 mg", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information