Label: LEADER NAUSEA RELIEF (dextrose (glucose), levulose- fructose, phosphoric acid solution
- NDC Code(s): 70000-0449-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated June 18, 2021
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- Active ingredients (per 5 mL)
- this product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI)
- 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
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
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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, 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 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 110, LLC. dba Leader (063997360)