Leg Cramp Relief

Causticum, Colocynthis, Cuprum Metallicum, Magnesia Phosphorica, Phytolacca Decandra, Rhus Tox, Stannum Metallicum, Veratrum Album


The Magni Company
Human Otc Drug
NDC 43689-0004
Leg Cramp Relief also known as Causticum, Colocynthis, Cuprum Metallicum, Magnesia Phosphorica, Phytolacca Decandra, Rhus Tox, Stannum Metallicum, Veratrum Album is a human otc drug labeled by 'The Magni Company'. National Drug Code (NDC) number for Leg Cramp Relief is 43689-0004. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Leg Cramp Relief drug includes Causticum - 12 [hp_X]/1 Citrullus Colocynthis Fruit Pulp - 12 [hp_X]/1 Copper - 12 [hp_X]/1 Magnesium Phosphate, Dibasic Trihydrate - 12 [hp_X]/1 Phytolacca Americana Root - 12 [hp_X]/1 Tin - 12 [hp_X]/1 Toxicodendron Pubescens Leaf - 12 [hp_X]/1 Veratrum Album Root - 12 [hp_X]/1 . The currest status of Leg Cramp Relief drug is Active.

Drug Information:

Drug NDC: 43689-0004
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Leg Cramp Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Causticum, Colocynthis, Cuprum Metallicum, Magnesia Phosphorica, Phytolacca Decandra, Rhus Tox, Stannum Metallicum, Veratrum Album
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: The Magni Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CAUSTICUM - 12 [hp_X]/1
CITRULLUS COLOCYNTHIS FRUIT PULP - 12 [hp_X]/1
COPPER - 12 [hp_X]/1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 12 [hp_X]/1
PHYTOLACCA AMERICANA ROOT - 12 [hp_X]/1
TIN - 12 [hp_X]/1
TOXICODENDRON PUBESCENS LEAF - 12 [hp_X]/1
VERATRUM ALBUM ROOT - 12 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 10 Oct, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 17 Dec, 2023
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 09 May, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:The Magni Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:M0005152
N0000175831
N0000008595
N0000008924
N0000175830
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:DD5FO1WKFU
23H32AOH17
789U1901C5
HF539G9L3Q
11E6VI8VEG
387GMG9FH5
6IO182RP7A
QNS6W5US1Z
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Copper-containing Intrauterine Device [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Inhibit Ovum Fertilization [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Copper [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Calculi Dissolution Agent [EPC]
Copper [CS]
Copper-containing Intrauterine Device [EPC]
Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Increased Large Intestinal Motility [PE]
Inhibit Ovum Fertilization [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
43689-0004-1125 TABLET in 1 BOTTLE (43689-0004-1)10 Oct, 201217 Dec, 2023No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Indications temporarily relieves muscle cramps that may be worse at night. these statements are supported by the traditional homeopathic principles.

Product Elements:

Leg cramp relief causticum, colocynthis, cuprum metallicum, magnesia phosphorica, phytolacca decandra, rhus tox, stannum metallicum, veratrum album causticum causticum citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp copper copper magnesium phosphate, dibasic trihydrate magnesium cation phytolacca americana root phytolacca americana root toxicodendron pubescens leaf toxicodendron pubescens leaf tin tin veratrum album root veratrum album root lactose magnesium stearate cellulose, microcrystalline convex ml

Indications and Usage:

Indications and usage temporarily relieves muscle cramps that may be worse at night.

Warnings:

Warnings if pregnant or breastfeeding, 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. tamper sealed: sealed for your protection. do not use if seal is broken or missing. store tightly closed in a cool, dry place (590-860f). the letters "hpus" indicate that the components in this product are officially monographed in the homeopathic pharmacopeia of the united states.

Dosage and Administration:

Directions adults and children 12 years and above, dissolve 2 tablets under tongue 2 to 3 times daily or as directed by a physician. children under 12 years of age, consult a physician.

Package Label Principal Display Panel:

Magni life homeopathic ndc 43689-0004-1 leg cramp relief relieves nightime cramping of the legs, calves, feet and toes 125 tablets leg cramp relief lbl leg cramp relief ctn

Further Questions:

Questions dist. by: the magni group, inc. mckinney, tx 75071 usa www.magnilife.com 1-800-645-9199


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.