Label: ANTI NAUSEA (dextrose(glucose),levulose- fructose,phosphoric acid liquid
- NDC Code(s): 70000-0052-1
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (per 5 mL)
- Purpose
- Uses
- Warnings
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Directions
- ▪
- for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product
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- repeat dose every 15 minutes or until distress subsides
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- do not take more than 5 doses in 1 hour without consulting a doctor
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- measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products.
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- mL= milliliter
- 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
- Inactive ingredients
- Questions or Comments?
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SPL UNCLASSIFIED SECTION
NDC 70000-0052-1
Compare to the active ingredients EMETROL®*
Relief from Nausea Due to Upset Stomach Safe and Effective for Children and Adults
- •
- No Antihistamines
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- No Salicylates
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- No Caffeine
Natural Cherry Flavor
4 FL OZ (118 mL)
LEADER™
Non-Drowsy
Children Adult
Nausea Relief
Dextrose (Glucose)
Levulose ( Fructose)
Phosphoric Acid
Upset Stomach Reliever
Cherry Flavor
IMPORTANT: Keep this carton for future reference on full labeling.
Distributed by:
*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation., owner of the registered trademark Emetrol®.
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
ANTI NAUSEA
dextrose(glucose),levulose(fructose),phosphoric acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0052 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) 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 (Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0052-1 1 in 1 CARTON 07/29/2020 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 07/27/2020 Labeler - Cardinal Health (063997360)
