NDC 63868-704 Anti Nausea Liquid Cherry Flavor

Dextrose(glucose),levulose(fructose),phosphoric Acid

NDC Product Code 63868-704

NDC Code: 63868-704

Proprietary Name: Anti Nausea Liquid Cherry Flavor What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextrose(glucose),levulose(fructose),phosphoric Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-704 - Anti Nausea Liquid

NDC 63868-704-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Anti Nausea Liquid Cherry Flavor with NDC 63868-704 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Anti Nausea Liquid Cherry Flavor is dextrose(glucose),levulose(fructose),phosphoric acid. The product's dosage form is solution and is administered via oral form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

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.

Anti Nausea Liquid Cherry Flavor 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, UNSPECIFIED FORM 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.

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

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.

Product Labeler Information

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

Labeler Name: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
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: 04-16-2019 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.

Anti Nausea Liquid Cherry Flavor Product Label Images

Anti Nausea Liquid Cherry Flavor 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 (Per 5 Ml)

  • Dextrose (glucose) 1.87 gLevulose (fructose) 1.87 g Phosphoric acid 21.5 mg

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= 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

  • •Store at room temperature away from heat and direct light; keep from freezing •Do not use if printed seal under cap is broken or missing

Inactive Ingredients

FD&C red no. 40, flavors, glycerin, methylparaben, purified water.

Other

  • NDC 63868-704-04*Compare to the Active Ingredients Emetrol®Anti-Nausea LiquidDoctor RecommendedRelief from Nausea Due to Upset Stomach Safe and Effective for Children and Adults •No Antihistamines •No Salicylates •No CaffeineCherry FlavorNaturally and Artificially Flavored4fl oz (118 mL)100% QC SATISFACTION GUARANTEEDIMPORTANT: Keep this carton for future reference on full labeling.DISTRIBUTED BY C.D.M.A., Inc. ©43157 W 9 Mile RdNovi, MI 48375www.qualitychoice.comQuestions: 800-935-2362*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation., owner of the registered trademark Emetrol®.

* Please review the disclaimer below.

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