Leader 44-073

Leader 44-073
SPL v2
SPL
SPL Set ID ebfcb699-3369-4697-9841-44015b1c9808
Route
ORAL
Published
Effective Date 2026-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-24

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 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 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 8 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, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER♥

NDC 70000-0670-1

Sugar-Free

Tussin DM

Cough + Chest

Congestion DM

Dextromethorphan HBr

Guaifenesin

Cough Suppressant | Expectorant

Cool Mint

Flavor

Controls Cough

Relieves Chest

Congestion

Thins & Loosens

Mucus

Dye-Free

Oral Solution

For Ages 12

& Over

COMPARE TO

ROBITUSSIN®

SUGAR-FREE

DYE-FREE

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®

Sugar-Free Dye-Free Cough+Chest Congestion DM.

50844        ORG062307336

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com      1-800-200-6313

Essential to Care™ since 1979

©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 44-073




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 200 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 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 8 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, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

LEADER♥

NDC 70000-0670-1

Sugar-Free

Tussin DM

Cough + Chest

Congestion DM

Dextromethorphan HBr

Guaifenesin

Cough Suppressant | Expectorant

Cool Mint

Flavor

Controls Cough

Relieves Chest

Congestion

Thins & Loosens

Mucus

Dye-Free

Oral Solution

For Ages 12

& Over

COMPARE TO

ROBITUSSIN®

SUGAR-FREE

DYE-FREE

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®

Sugar-Free Dye-Free Cough+Chest Congestion DM.

50844        ORG062307336

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com      1-800-200-6313

Essential to Care™ since 1979

©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 44-073




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 200 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


Raw Label Data

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