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NDC 70000-0449-01 leader nausea relief 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL Details

leader nausea relief 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL

leader nausea 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 DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID.

Product Information

NDC	70000-0449
Product ID	70000-0449_609aad0c-e36d-4fa1-8ab5-bfd23965ffc7
Associated GPIs	50309903602000
GCN Sequence Number	004698
GCN Sequence Number Description	phosphorated carbo(dext-fruct) SOLUTION ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	73710
HICL Sequence Number	015060
HICL Sequence Number Description	PHOSPHORATED CARBOHYDRATE (DEXTROSE AND FRUCTOSE)
Brand/Generic	Generic
Proprietary Name	leader nausea relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextrose (glucose), Levulose (fructose), Phosphoric Acid
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	1.87; 1.87; 21.5
Active Ingredient Units	g/5mL; g/5mL; mg/5mL
Substance Name	DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0449-01 (70000044901)

Pricing Information
NDC Package Code	70000-0449-1
Billing NDC	70000044901
Package	1 BOTTLE in 1 CARTON (70000-0449-1) / 118 mL in 1 BOTTLE
Marketing Start Date	2018-11-27
NDC Exclude Flag	N
Price Per Unit	0.02023
Pricing Unit	ML
Effective Date	2022-01-19
NDC Description	NAUSEA RELIEF LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-01-26

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 42b3e977-7600-4297-90fa-91a037aec5d2 Details

Active ingredients (per 5 mL)

Dextrose (glucose) 1.87g

Levulose (fructose) 1.87g

Phosphoric acid 21.5mg

Purpose

Upset stomach reliever

Uses

•: for relief of upset stomach associated with nausea

Warnings

•: this product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI)

Do not use

if you have

•: allergic reactions to any of the ingredients in this product

Ask a doctor before use if you have

•: diabetes

Stop use and ask a doctor if

•: symptoms persist, return or get worse

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

•: for maximum effectiveness, never dilute or drink fluids of any kind immediately before or after taking this product
•: repeat dose every 15 minutes or until distress subsides
•: do not take more than 5 doses in 1 hour without consulting a doctor
•: measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products.
•: mL = milliliters

age	dose
adults and children 12 years of age and over	15 mL or 30 mL
children 2 to under 12 years of age	5 mL or 10 mL

Other information

•: store at 20-25°C (68-77°F) away from heat and direct light; keep from freezing.
•: do not use if printed neckband is broken or missing

Inactive ingredients

FD&C red no. 40 aluminum lake, flavor, glycerin, methylparaben, purified water

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Children | Adult

Nausea Relief

Dextrose (Glucose)

Levulose (Fructose)

Phosphoric Acid

Nausea & Upset Stomach

Cherry Flavor

Antihistamine-Free

Aspirin-Free

Alcohol-Free

Caffeine-Free

COMPARE TO EMETROL® active ingredients

100% Money Back Guarantee

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

LEADER NAUSEA RELIEF

dextrose (glucose), levulose (fructose), phosphoric acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0449
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2)	DEXTROSE, UNSPECIFIED FORM	1.87 g in 5 mL
FRUCTOSE (UNII: 6YSS42VSEV) (FRUCTOSE - UNII:6YSS42VSEV)	FRUCTOSE	1.87 g in 5 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	21.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0449-1	1 in 1 CARTON	11/27/2018
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
Unapproved drug other		11/27/2018

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

Revised: 6/2021

Document Id: 609aad0c-e36d-4fa1-8ab5-bfd23965ffc7

Set id: 42b3e977-7600-4297-90fa-91a037aec5d2

Version: 2

Effective Time: 20210618