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Leader nausea relief - Medication Information

Product NDC Code 70000-0449
Drug Name

Leader nausea relief

Type Brand
Active Ingredients
Dextrose, unspecified form 1.87 g/5ml
Fructose 1.87 g/5ml
Phosphoric acid 21.5 mg/5ml
Route ORAL
Dosage Form SOLUTION
RxCUI drug identifier 318146
Labeler Name Cardinal Health 110, LLC. dba Leader
Packages
Package NDC Code Description
70000-0449-1 1 bottle in 1 carton (70000-0449-1) / 118 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (per 5 mL) Dextrose (glucose) 1.87g Levulose (fructose) 1.87g Phosphoric acid 21.5mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
agedose
adults and children 12 years of age and over15 mL or 30 mL
children 2 to under 12 years of age5 mL or 10 mL

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C red no. 40 aluminum lake, flavor, glycerin, methylparaben, purified water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses • for relief of upset stomach associated with nausea

Purpose

Information about the drug product’s indications for use.
Purpose Upset stomach reliever

Spl product data elements

Usually a list of ingredients in a drug product.
leader nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid DEXTROSE, UNSPECIFIED FORM DEXTROSE, UNSPECIFIED FORM FRUCTOSE FRUCTOSE PHOSPHORIC ACID PHOSPHORIC ACID FD&C RED NO. 40 GLYCERIN METHYLPARABEN WATER clear

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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) 291-e9-nausea-relief.jpg

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have • diabetes

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have • allergic reactions to any of the ingredients in this product

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-719-9260

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if • symptoms persist, return or get worse

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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).

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API