NDC 0113-0112 Good Sense Nausea Relief

Dextrose (glucose), Levulose (fructose), Phosphoric Acid

NDC Product Information

Good Sense Nausea Relief with NDC 0113-0112 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Nausea Relief is dextrose (glucose), levulose (fructose), phosphoric acid. The product's dosage form is solution and is administered via oral form.

Labeler Name: L. Perrigo Company

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Good Sense Nausea Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE 1.87 g/5mL
  • FRUCTOSE 1.87 g/5mL
  • PHOSPHORIC ACID 21.5 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-03-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Good Sense Nausea Relief Product Label Images

Good Sense Nausea Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

  • Phosphorated carbohydrate solution**Each 5mL contains: •3.74g Total sugar [dextrose (glucose) 1.87g, levulose (fructose) 1.87g] •21.5mg Phosphoric acid

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 •adults and children 12 years of age and over: 15 mL to 30 mL •children 2 to under 12: 5 mL to 10 mL •repeat dose every 15 minutes or until distress subsides •do not take more than 5 doses in 1 hour without consulting a doctor •only use the dose cup provided

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

* Please review the disclaimer below.