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NDC 70000-0596-02 leader tussin dm 20; 200 mg/20mL; mg/20mL Details

leader tussin dm 20; 200 mg/20mL; mg/20mL

leader tussin dm is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 70000-0596-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 70000-0596-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70000-0596
Product ID	70000-0596_b418c10c-528b-4395-944e-af959b639ec2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	leader tussin dm
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan hydrobromide, guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	20; 200
Active Ingredient Units	mg/20mL; mg/20mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0596-02 (70000059602)

Pricing Information	N/A
NDC Package Code	70000-0596-2
Billing NDC	70000059602
Package	1 BOTTLE in 1 CARTON (70000-0596-2) / 237 mL in 1 BOTTLE
Marketing Start Date	2021-11-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b418c10c-528b-4395-944e-af959b639ec2 Details

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

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

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

•: cough that occurs with too much phlegm (mucus)
•: cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

•: do not take more than 6 doses in any 24-hour period
•: measure only with dosing cup provided
•: keep dosing cup with product
•: mL = milliliter
•: this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	20 mL every 4 hours
children under 12 years	do not use

Other information

•: each 20 mL contains: sodium 14 mg
•: store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER™

Adult | Non-Drowsy

Tussin DM

Cough + Chest Congestion DM

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Cough Suppressant | Expectorant

Raspberry Flavor

For Ages 12 & Over

Controls Cough

Relieves Chest Congestion

Thins & Loosens Mucus

COMPARE TO ROBITUSSIN® COUGH+CHEST CONGESTION DM

active ingredients

100% Money Back Guarantee

4 FL OZ (118 mL)

SEE NEW DOSING

INGREDIENTS AND APPEARANCE

LEADER TUSSIN DM

dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0596
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0596-1	1 in 1 CARTON	11/24/2021
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:70000-0596-2	1 in 1 CARTON	11/24/2021
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/24/2021

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 12/2021

Document Id: b418c10c-528b-4395-944e-af959b639ec2

Set id: b418c10c-528b-4395-944e-af959b639ec2

Version: 1

Effective Time: 20211209