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NDC 70000-0193-01 Leader Nighttime Cough 30; 12.5 mg/30mL; mg/30mL Details

Leader Nighttime Cough 30; 12.5 mg/30mL; mg/30mL

Leader Nighttime Cough 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; DOXYLAMINE SUCCINATE.

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: 70000-0193-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 70000-0193-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	70000-0193
Product ID	70000-0193_cefe432b-99ca-4f90-b5dd-82aa3517a062
Associated GPIs	43995702200920
GCN Sequence Number	060513
GCN Sequence Number Description	dextromethorphan hb/doxylamine SOLUTION 15-6.25/15 ORAL
HIC3	B4E
HIC3 Description	NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB.
GCN	26684
HICL Sequence Number	000392
HICL Sequence Number Description	DEXTROMETHORPHAN HBR/DOXYLAMINE SUCCINATE
Brand/Generic	Generic
Proprietary Name	Leader Nighttime Cough
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	30; 12.5
Active Ingredient Units	mg/30mL; mg/30mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 70000-0193-01 (70000019301)

Pricing Information
NDC Package Code	70000-0193-1
Billing NDC	70000019301
Package	355 mL in 1 BOTTLE (70000-0193-1)
Marketing Start Date	2016-11-29
NDC Exclude Flag	N
Price Per Unit	0.01235
Pricing Unit	ML
Effective Date	2023-05-17
NDC Description	NIGHTTIME COUGH LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-14

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 5d3772a1-4e5d-4621-bf50-0fa0acb13081 Details

Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms:

•: cough due to minor throat and bronchial irritation
•: runny nose and sneezing

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

•: glaucoma
•: cough that occurs with too much phlegm (mucus)
•: a breathing problem such as emphysema or chronic bronchitis
•: persistent or chronic cough as occurs with smoking, asthma, or emphysema
•: trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•: excitability may occur, especially in children
•: may cause marked drowsiness
•: avoid alcoholic drinks
•: be careful when driving a motor vehicle or operating machinery
•: alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

: cough persists for more than 1 week, tends to recur, 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

•: take only as directed
•: only use the dose cup provided
•: do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Other information

•: each 30 mL contains: sodium 32 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

LEADER™

Nighttime Cough

Dextromethorphan HBr, 30 mg

Doxylamine Succinate, 12.5 mg

Cough Suppressant

Antihistamine

Cherry Flavor

Relief of:

Cough

Sneezing

Runny Nose

COMPARE TO VICKS® NYQUIL® COUGH

active ingredients

ALCOHOL 10%

100% Money Back Guarantee

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

LEADER NIGHTTIME COUGH

dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0193
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 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0193-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/29/2016

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

Revised: 6/2022

Document Id: cefe432b-99ca-4f90-b5dd-82aa3517a062

Set id: 5d3772a1-4e5d-4621-bf50-0fa0acb13081

Version: 4

Effective Time: 20220608