NDC 55714-4640 Cardiac Care

Elaps Corallinus, Aconitum Nap., Arsenicum Alb., Aur. Met., Baryta Carb., Benzoicum Acidum, Berber. Vulg., Bryonia, Calc. Fluor. , Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Convallaria, Crotalus Horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum Acidum, Kali Iodatum, Lachesis, Lycopus Virginicus, Naja, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron , Vipera Berus, Echinacea, Hypericum,valeriana

NDC Product Code 55714-4640

NDC Code: 55714-4640

Proprietary Name: Cardiac Care 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: Elaps Corallinus, Aconitum Nap., Arsenicum Alb., Aur. Met., Baryta Carb., Benzoicum Acidum, Berber. Vulg., Bryonia, Calc. Fluor. , Cantharis, Ceanothus, Chelidonium Majus, Chionanthus Virginica, Cinchona, Convallaria, Crotalus Horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum Acidum, Kali Iodatum, Lachesis, Lycopus Virginicus, Naja, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron , Vipera Berus, Echinacea, Hypericum,valeriana 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-4640 - Cardiac Care

NDC 55714-4640-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC 55714-4640-2

Package Description: 59 mL in 1 BOTTLE, GLASS

NDC Product Information

Cardiac Care with NDC 55714-4640 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Cardiac Care is elaps corallinus, aconitum nap., arsenicum alb., aur. met., baryta carb., benzoicum acidum, berber. vulg., bryonia, calc. fluor. , cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, convallaria, crotalus horridus, digitalis, gelsemium , glonoinum, hydroflouricum acidum, kali iodatum, lachesis, lycopus virginicus, naja, nux vom., phosphorus, pulsatilla, rhus toxicodendron , vipera berus, echinacea, hypericum,valeriana. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, 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 Prescription 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.

Cardiac Care 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.

  • POTASSIUM IODIDE 10 [hp_X]/mL
  • LACHESIS MUTA VENOM 10 [hp_X]/mL
  • LYCOPUS VIRGINICUS 10 [hp_X]/mL
  • NAJA NAJA VENOM 10 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 10 [hp_X]/mL
  • PHOSPHORUS 10 [hp_X]/mL
  • PULSATILLA VULGARIS 10 [hp_X]/mL
  • MICRURUS CORALLINUS VENOM 30 [hp_X]/mL
  • ACONITUM NAPELLUS 10 [hp_X]/mL
  • ARSENIC TRIOXIDE 10 [hp_X]/mL
  • GOLD 10 [hp_X]/mL
  • BARIUM CARBONATE 10 [hp_X]/mL
  • BENZOIC ACID 10 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 10 [hp_X]/mL
  • BRYONIA ALBA ROOT 10 [hp_X]/mL
  • CALCIUM FLUORIDE 10 [hp_X]/mL
  • LYTTA VESICATORIA 10 [hp_X]/mL
  • CEANOTHUS AMERICANUS LEAF 10 [hp_X]/mL
  • CHELIDONIUM MAJUS 10 [hp_X]/mL
  • CHIONANTHUS VIRGINICUS BARK 10 [hp_X]/mL
  • CONVALLARIA MAJALIS 10 [hp_X]/mL
  • CROTALUS HORRIDUS HORRIDUS VENOM 10 [hp_X]/mL
  • DIGITALIS 10 [hp_X]/mL
  • HYDROFLUORIC ACID 10 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X]/mL
  • NITROGLYCERIN 10 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 10 [hp_X]/mL
  • VIPERA BERUS VENOM 10 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • HYPERICUM PERFORATUM 3 [hp_X]/mL
  • VALERIAN 3 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 10 [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.

  • 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
  • Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)
  • Nitrate Vasodilator - [EPC] (Established Pharmacologic Class)
  • Nitrates - [CS]
  • Vasodilation - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
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: 04-17-2017 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.

Cardiac Care Product Label Images

Cardiac Care 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

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Pregnancy Or Breast Feeding Section

If
​pregnant or breast-feeding, ​ask a doctor before use.

Warnings Section

Warning:​Keep out of reach of children. Do not use​ if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If
​pregnant or breast-feeding,​ ask a doctor before use.

Questions? Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Purpose Section

Formulated for symptoms associated with arteriosclerosis, tachycardia, arrhythmias, palpitations and other related conditions.

Active Ingredient Section

Equal parts of Echinacea 3x, Hypericum 3x,Valeriana 3x, Aconitum nap. 10x, Arsenicum alb. 10x, Aur. met.10x, Baryta carb. 10x, Benzoicum acidum 10x, Berber. vulg. 10x, Bryonia 10x, Calc. fluor. 10x, Cantharis 10x, Ceanothus 10x, Chelidonium majus 10x, Chionanthus virginica 10x, Cinchona 10x, Convallaria 10x, Crotalus horridus 10x, Digitalis 10x, Gelsemium 10x, Glonoinum 10x, Hydroflouricum acidum 10x, Kali iod.10x, Lachesis 10x, Lycopus virginicus 10x, Naja 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Vipera berus 10x, Elaps corallinus 30x.

Dosage & Administration Section

Directions:. Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

Indications & Usage Section

CARDIAC Care Formulated for symptoms associated with arteriosclerosis, tachycardia, arrhythmias, palpitations and other related conditions.

* Please review the disclaimer below.

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