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NDC 70000-0465-01 Leader Maximum Strength Mucus Relief DM 20; 400 mg/20mL; mg/20mL Details

Leader Maximum Strength Mucus Relief DM 20; 400 mg/20mL; mg/20mL

Leader Maximum Strength Mucus Relief DM is a ORAL LIQUID 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: 70000-0465-01
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: 70000-0465-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70000-0465
Product ID	70000-0465_a339e9ce-bc00-4467-ad90-d8cb333ee0a7
Associated GPIs	43997002520905
GCN Sequence Number	023893
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 100-5 MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53497
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Leader Maximum Strength Mucus Relief DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	20; 400
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	2023-12-31

Package

Package Images

NDC 70000-0465-01 (70000046501)

Pricing Information
NDC Package Code	70000-0465-1
Billing NDC	70000046501
Package	177 mL in 1 BOTTLE (70000-0465-1)
Marketing Start Date	2019-07-23
NDC Exclude Flag	N
Price Per Unit	0.01972
Pricing Unit	ML
Effective Date	2022-07-20
NDC Description	MUCUS RELIEF DM MAX LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2022-08-31

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 22efdf17-92c7-4670-8470-4f99d24ce7de Details

ACTIVE INGREDIENTS (in each 20 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

PURPOSE

Cough Suppressant

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep

WARNINGS

DO NOT USE

for children under 12 years of age
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

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

WHEN USING THIS PRODUCT

do not use more than directed

STOP USE AND ASK DOCTOR IF

cough lasts more than 7 days, comes back, or occurs with 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 take more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
Adults & children 12 years & older: 20 mL every 4 hours
Children under 12 years of age: Do not use

OTHER INFORMATION

each 20 mL contains: potassium 20 mg, sodium 20 mg
store between 15-30°C (59-86°F)
do not refrigerate
dosing cup provided

INACTIVE INGREDIENTS

citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0465-1

Maximum Strength

Mucus

Relief DM

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Cough Suppressant / Expectorant

For Ages 12 & Over

Multi-Symptom

Relieves Chest Congestion

Controls Cough

Thins and loosens Mucus

COMPARE TO MUCINEX FAST MAX DM MAX active ingredients*

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH MUCUS RELIEF DM

dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0465
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	400 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0465-1	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/23/2019

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Revised: 1/2022

Document Id: a339e9ce-bc00-4467-ad90-d8cb333ee0a7

Set id: 22efdf17-92c7-4670-8470-4f99d24ce7de

Version: 3

Effective Time: 20220111