NDC 62795-4004 Reboost

Apis Mellifera, Atropa Belladonna, Zinc Gluconate, Baptisia Tinctoria Root, Ulmus Rubra Bark, Sulfur, Zinc Acetate Anhydrous, Vincetoxicum Hirundinaria Root And Cairina Moschata Heart/liver

NDC Product Information

Reboost with NDC 62795-4004 is a a human over the counter drug product labeled by Medinatura. The generic name of Reboost is apis mellifera, atropa belladonna, zinc gluconate, baptisia tinctoria root, ulmus rubra bark, sulfur, zinc acetate anhydrous, vincetoxicum hirundinaria root and cairina moschata heart/liver. The product's dosage form is spray and is administered via oral form.

Labeler Name: Medinatura

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Reboost 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.

  • APIS MELLIFERA 6 [hp_X]/20mL
  • ATROPA BELLADONNA 5 [hp_X]/20mL
  • CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X]/20mL
  • ECHINACEA PURPUREA 4 [hp_X]/20mL
  • GOLDENSEAL 5 [hp_X]/20mL
  • PHYTOLACCA AMERICANA ROOT 4 [hp_X]/20mL
  • PLANTAGO MAJOR 3 [hp_X]/20mL
  • SAGE 3 [hp_X]/20mL
  • ZINC GLUCONATE 1 [hp_X]/20mL
  • BAPTISIA TINCTORIA ROOT 1 [hp_X]/20mL
  • ULMUS RUBRA BARK 1 [hp_X]/20mL
  • SULFUR 4 [hp_X]/20mL
  • ZINC ACETATE ANHYDROUS 4 [hp_X]/20mL
  • VINCETOXICUM HIRUNDINARIA ROOT 6 [hp_X]/20mL
  • CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 20 [hp_X]/20mL

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)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • WATER (UNII: 059QF0KO0R)
  • CHERRY (UNII: BUC5I9595W)

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: Medinatura
Labeler Code: 62795
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: 02-05-2020 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: 12-31-2021 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.

Reboost Product Label Images

Reboost 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

Each 20ml containsActive Ingredients Purpose*Apis mellifica 6X 1.25%*Asclepias Vincetoxicum 6X 10X 30X 1.25%*Belladonna 5X 1.25%*Organic Calendula officinalis 4X 1.25%*Organic Echinacea purpurea 4X 1.25%*Hydrastis canadensis 5X 1.25%*Phytolacca decandra 4X 1.25%*Plantago major 3X 1.25%*Salvia officinalis 3X 1.25%*Zincum Gluconlcum 1X 2.5%*Wild Harvested Baptisia Tinctoria 1X 1.25%*Ulmus Fulva 1X 1.25%*Sulphur 4X 10X 1.25%*Zincum Aceticum 4X 2.5%*Anas Barbariae 20X 200C 1.25%*Natural Ingredients

Inactive Ingredients

Ethanol, Glycerol, Natural Cherry Flavor, Fructose, Purified Water.

Uses

Uses:To reduce cold and flu symptoms and temporary relief minor sore throat pain, headache, chills, fatigue,bodyaches, cough and runny nose.

Directions

Directions: Adults and children 12 years and older: 2 sprays onto affected area every 2-4 hours. Do not exceed 24 sprays in  24 hours.For Children under 12 years:  consult your health professional.

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a health professional promptly. Do not use more than 2 days. This product contains ethanol and should not be inhaled. In rare cases allergic reactions may occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. The use of this a by more than one person may spread infection. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to ReBoost™ or any of its ingredients exists.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Indications

Reduces cold and flu symptomsReleive sore throat pain, chills, head aches, body aches, cough, runny nose and fatigue

* Please review the disclaimer below.