LEADER NAUSEA RELIEF (dextrose (glucose), levulose- fructose, phosphoric acid solution

leader nausea relief by

Drug Labeling and Warnings

leader nausea relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2)	DEXTROSE	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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/27/2018

Labeler - Cardinal Health (097537435)