NDC 54638-0003 Rehydrate

Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden

NDC Product Code 54638-0003

NDC Code: 54638-0003

Proprietary Name: Rehydrate 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: Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden 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

  • 54638 - Paradocs All Natural, Inc.
    • 54638-0003 - Rehydrate

NDC 54638-0003-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Rehydrate with NDC 54638-0003 is a a human over the counter drug product labeled by Paradocs All Natural, Inc.. The generic name of Rehydrate is avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, silicea, pueraria lobata, carlsbad aqua, adenosinum triphosphoricum dinatrum, germanium sesquioxide, hydrogen, oxygen, wiesbaden. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Paradocs All Natural, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Rehydrate 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.

  • AVENA SATIVA FLOWERING TOP 3 [hp_X]/mL
  • EQUISETUM HYEMALE 4 [hp_X]/mL
  • HYPERICUM PERFORATUM 6 [hp_X]/mL
  • ULMUS RUBRA BARK 6 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 12 [hp_X]/mL
  • SILICON DIOXIDE 12 [hp_X]/mL
  • PUERARIA MONTANA VAR. LOBATA ROOT 8 [hp_C]/mL
  • WATER 12 [hp_C]/mL
  • ADENOSINE TRIPHOSPHATE DISODIUM 30 [hp_C]/mL
  • GERMANIUM SESQUIOXIDE 30 [hp_C]/mL
  • HYDROGEN 30 [hp_C]/mL
  • OXYGEN 30 [hp_C]/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BEET (UNII: N487KM8COK)
  • CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)
  • PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
  • TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
  • PARSLEY (UNII: 58FMD0Q0EV)
  • CHELIDONIUM MAJUS (UNII: 7E889U5RNN)

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: Paradocs All Natural, Inc.
Labeler Code: 54638
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 02-12-2015 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: 12-31-2019 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.

Rehydrate Product Label Images

Rehydrate 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:

Avena Sativa 3X, Equisetum Hyemale 4X, Hypericum Perforatum 6X, Ulmus Fulva 6X, Glycyrrhiza Glabra 12X, Silicea 12X, Pueraria Lobata 8C, Carlsbad Aqua 12C, Adenosinum Triphosphoricum Dinatrum 30C, Germanium Sesquioxide 30C, Hydrogen 30C, Oxygen 30C, Wiesbaden 30C.

Indications:

To aid with proper hydration.

To aid with proper hydration.

Warnings:

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.Do not use if tamper evident seal is broken or missing.Store in a cool, dry place.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

One drop per ounce of pure water. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, Ethanol 9%, Glycerin, Propriety Extract blend of Beet (Root), Blessed Thistle (Aerial Parts), Boldo (Leaf), Celandine (Aerial Parts), Dandelion (Root), Parsley (Leaf)

Questions:

MFD. FOR:ParaDocs All Natural Inc.2640 E. Oakland Park Blvd.Ft. Lauderdale, FL 33306

Package Label Display:

ReHydrateHomeopathic2 FL OZ (60 ml)

* Please review the disclaimer below.

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