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NDC 70000-0302-01 Leader Cough 30 mg/5mL Details

Leader Cough 30 mg/5mL

Leader Cough is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

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: 70000-0302-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	70000-0302
Product ID	70000-0302_705b6716-957d-40f2-b881-8fd36f0ea549
Associated GPIs	4310203060G110
GCN Sequence Number	004630
GCN Sequence Number Description	dextromethorphan polistirex SUS ER 12H 30 MG/5 ML ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17802
HICL Sequence Number	010295
HICL Sequence Number Description	DEXTROMETHORPHAN POLISTIREX
Brand/Generic	Generic
Proprietary Name	Leader Cough
Proprietary Name Suffix	DM
Non-Proprietary Name	dextromethorphan polistirex
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091135
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0302-01 (70000030201)

Pricing Information
NDC Package Code	70000-0302-1
Billing NDC	70000030201
Package	1 BOTTLE in 1 CARTON (70000-0302-1) / 89 mL in 1 BOTTLE
Marketing Start Date	2017-06-06
NDC Exclude Flag	N
Price Per Unit	0.06416
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	COUGH DM ER 30 MG/5 ML SUSP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

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 a07b70d0-3842-4ea6-abb4-95b4638d5e55 Details

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

•: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
•: the impulse to cough to help you get to sleep

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have

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

Stop use and ask a doctor if

•: side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
•: cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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 (1-800-222-1222).

Directions

•: shake bottle well before use
•: measure only with dosing cup provided
•: do not use dosing cup with other products
•: dose as follows or as directed by a doctor


adults and children 12 years of age and over	10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age	5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age	2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of age	do not use

Other information

•: each 5 mL contains: sodium 5 mg
•: store at 20° to 25°C (68° to 77°F)
•: dosing cup provided

Inactive ingredients

artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Day or Night

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

Grape Flavored Liquid

12 Hour Cough Relief

Alcohol-Free

Dosing Cup Included

COMPARE TO DELSYM® active ingredient

100% Money Back Guarantee

Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions

3 FL OZ (89 mL)

DO NOT USE IF CARTON IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

INGREDIENTS AND APPEARANCE

LEADER COUGH DM

dextromethorphan polistirex suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0302
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ACETATE (UNII: 32K497ZK2U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
SUCROSE (UNII: C151H8M554)
TARTARIC ACID (UNII: W4888I119H)
TRAGACANTH (UNII: 2944357O2O)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)
D&C RED NO. 30 (UNII: 2S42T2808B)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0302-1	1 in 1 CARTON	06/06/2017
1		89 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
ANDA	ANDA091135	06/06/2017

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

Revised: 6/2021

Document Id: 705b6716-957d-40f2-b881-8fd36f0ea549

Set id: a07b70d0-3842-4ea6-abb4-95b4638d5e55

Version: 4

Effective Time: 20210617