NDC 64616-109 Cal-5-revive

Calcium Balance

NDC Product Information

Cal-5-revive with NDC 64616-109 is a a human over the counter drug product labeled by Vitality Works, Inc.. The generic name of Cal-5-revive is calcium balance. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Vitality Works, 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.

Cal-5-revive 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.

  • ACONITUM NAPELLUS 20 [hp_X]/mL
  • BISMUTH SUBNITRATE 15 [hp_X]/mL
  • CALCIUM ARSENATE 12 [hp_X]/mL
  • CALCIUM HYDROXIDE 27 [hp_X]/mL
  • CALCIUM FLUORIDE 25 [hp_X]/mL
  • CALCIUM IODIDE 10 [hp_X]/mL
  • CALCIUM OXALATE MONOHYDRATE 30 [hp_X]/mL
  • ELAEIS GUINEENSIS FRUIT 20 [hp_X]/mL
  • HELIANTHUS ANNUUS FLOWERING TOP 22 [hp_X]/mL
  • HYDRANGEA ARBORESCENS ROOT 14 [hp_X]/mL
  • IPECAC 24 [hp_X]/mL
  • IRIS GERMANICA VAR. FLORENTINA ROOT 23 [hp_X]/mL
  • POTASSIUM ARSENITE ANHYDROUS 20 [hp_X]/mL
  • POTASSIUM CHLORATE 30 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 22 [hp_X]/mL
  • MANGANESE ACETATE TETRAHYDRATE 22 [hp_X]/mL
  • MERCURIUS SOLUBILIS 30 [hp_X]/mL
  • OSMIUM 22 [hp_X]/mL
  • PHOSPHORIC ACID 36 [hp_X]/mL
  • SANGUINARINE NITRATE 17 [hp_X]/mL
  • TELLURIUM 27 [hp_X]/mL
  • ZINC GLUCONATE 30 [hp_X]/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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Vitality Works, Inc.
Labeler Code: 64616
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: 03-20-2013 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.

Cal-5-revive Product Label Images

Cal-5-revive 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

Cal-5-Revive

Aconitum Mapellus 20X                        Helianthus annuus 22X                           Mercurius Solubilis 10X, 30XBismuthum Subritricum 15X                 Hydrangea arborescens 14X                   Osmium metallicum 22XCalcarea arsenicica 12X                      Ipecacuanha 24X                                     Phosphoricum Acidum 36XCalcarea caustica 12X                         Iris florentina 23X                                    Sanguinarirnum nitricum 17XCalcarea fluorica 15X, 25X                  Kali arsenicosum 20X                               Tellurium metallicum 27XCalcerea iodata 10X                           Kali chloricum 11X, 22X,  30X                    Zincum gluconicum 10X, 30XCalcerea oxalica 15X, 30X                  Magnesia phosphorica 22XElaeis Guineensis 20X                        Manganum aceticum 22X

Alcohol, Purified Water

Use only under the direction of a health care professional.

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

For the temporary relief of muscular tension and aches, joint pain, mental stress and tiredness, racing or irregular heartbeat, physical and emotional tension, digestive discomfort, general unrest and sleeplessness.

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

Assists with distribution and usage of calcium.

* Please review the disclaimer below.