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NDC 70000-0008-01 leader childrens mucus and cough relief 5; 100 mg/5mL; mg/5mL Details

leader childrens mucus and cough relief 5; 100 mg/5mL; mg/5mL

leader childrens mucus and cough relief 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: 70000-0008-01
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: 70000-0008-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70000-0008
Product ID	70000-0008_21ff8830-55fc-4f93-a854-a5750e3ba605
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 childrens mucus and cough relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan hbr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
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	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0008-01 (70000000801)

Pricing Information
NDC Package Code	70000-0008-1
Billing NDC	70000000801
Package	1 BOTTLE in 1 CARTON (70000-0008-1) / 118 mL in 1 BOTTLE
Marketing Start Date	2020-01-28
NDC Exclude Flag	N
Price Per Unit	0.02132
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHILD MUCUS-COUGH 5-100 MG/5 ML
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 bbc8b52d-9f2a-4c96-871c-bb6dc8fc34c9 Details

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purpose

Cough suppressant

Expectorant

Uses

•: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
•: temporarily relieves:
•: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
•: the intensity of coughing
•: the impulse to cough to help your child get to sleep

Warnings

Do not use

in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

•: cough that occurs with too much phlegm (mucus)
•: persistent or chronic cough such as occurs with asthma

Stop use and ask a 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.

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
•: do not use dosing cup with other products
•: mL = milliliter

Age	Dose
children 6 years to under 12 years	5 mL - 10 mL every 4 hours
children 4 years to under 6 years	2.5 mL – 5 mL every 4 hours
children under 4 years	do not use

Other information

•: do not use if printed neckband is broken or missing
•: store at 20-25°C (68-77°F)
•: do not refrigerate
•: dosing cup provided

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Children’s Mucus & Cough Relief

Guaifenesin, 100 mg

Dextromethorphan HBr, 5 mg

Expectorant | Cough Suppressant

Cherry Flavor Liquid

Age 4+

Cough

Chest Congestion

Loosens Mucus

Alcohol-Free

COMPARE TO CHILDREN’S MUCINEX® COUGH active ingredients

100% Money Back Guarantee

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

LEADER CHILDRENS MUCUS AND COUGH RELIEF

dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	RED (Dark Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0008-1	1 in 1 CARTON	01/28/2020
1		118 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	01/28/2020

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

Revised: 6/2021

Document Id: 21ff8830-55fc-4f93-a854-a5750e3ba605

Set id: bbc8b52d-9f2a-4c96-871c-bb6dc8fc34c9

Version: 2

Effective Time: 20210617