NDC 49726-047 Restulex

Bufo Rana, Causticum, Chamomilla, Crotalus Horridus, Digitalis Purpurea, Lachesis Mutus, Lilium Tigrinum, Pulsatilla (pratensis) Rhus Tox, Sulphur, Tarentula Hispana, Viscum Album, Zincum Metallicum.

NDC Product Code 49726-047

NDC 49726-047-60

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Restulex with NDC 49726-047 is a a human over the counter drug product labeled by Hellolife, Inc.. The generic name of Restulex is bufo rana, causticum, chamomilla, crotalus horridus, digitalis purpurea, lachesis mutus, lilium tigrinum, pulsatilla (pratensis) rhus tox, sulphur, tarentula hispana, viscum album, zincum metallicum.. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hellolife, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Restulex 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.

  • BUFO BUFO CUTANEOUS GLAND 10 [hp_X]/1
  • CAUSTICUM 10 [hp_X]/1
  • MATRICARIA CHAMOMILLA 10 [hp_X]/1
  • CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X]/1
  • DIGITALIS 10 [hp_X]/1
  • LACHESIS MUTA VENOM 10 [hp_X]/1
  • LILIUM LANCIFOLIUM WHOLE FLOWERING 10 [hp_X]/1
  • ANEMONE PRATENSIS 10 [hp_X]/1
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/1
  • SULFUR 10 [hp_X]/1
  • LYCOSA TARANTULA 10 [hp_X]/1
  • VISCUM ALBUM FRUIT 10 [hp_X]/1
  • ZINC 10 [hp_X]/1

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.

  • COPOVIDONE K25-31 (UNII: D9C330MD8B)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITOL (UNII: 506T60A25R)

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: Hellolife, Inc.
Labeler Code: 49726
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: 10-10-2019 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.

Restulex Product Label Images

Restulex 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 Hpus Ingredients:

Bufo Rana 10X, 30X, 200C, Causticum 10X, 30X, 200C, Chamomilla 10X, 30X, 200C, Crotalus Horridus 10X, 30X, 200C, Digitalis Purpurea 10X, 30X, 200C, Lachesis Mutus 10X, 30X, 200C, Lilium Tigrinum 10X, 30X, 200C, Pulsatilla (Pratensis) 10X, 30X, 200C, Rhus Tox 10X, 30X, 200C, Sulphur 10X, 30X, 200C, Tarentula Hispana 10X, 30X, 200C, Viscum Album 10X, 30X, 200C, Zincum Metallicum 10X, 30X, 200C.

Indications For Use:

For the temporary relief of symptoms such as:• twitching • burning• heaviness• jerking• cramping• painProduct indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

For the temporary relief of symptoms such as:• twitching• burning• heaviness• jerking• cramping• painProduct indications are based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

Warnings:

Stop use and as a doctor if symptoms persist or worsen.


If pregnant or breast-feeding, ask health professional before use.


Do not use if tamper seal is broken.

Storage & Handling:

Do not store next to electrical devices or appliances.Keep lid tightly closed & 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:

Dissolve under tongue. 30-50lb (13.6kg-22.6kg): twice daily.50lb+ (22.6kg): 1 tablet twice daily.

Inactive Ingredients:

Copovidone, Crospovidone, Lactose, Magnesium, Stearate, Mannitol, Microcrystalline, Cellulose, Silicon Dioxide, Sorbitol.

Questions:

Dist. by: HelloLife, Inc.4635 40th St SEGrand Rapids, MI 49512www.hellolife.net

Package Label Display:

NDC 49726-047-60RESTULEXTABLETSNatural Relief for Restless Leg SymptomsHomeopathic (OTC) Medicine60 Quick-dissolving Tablets

* Please review the disclaimer below.