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Cardio tonic - Prescription Drug Labeling

Product NDC Code 43857-0073
Drug Name

Cardio tonic

Type Brand
Active Ingredients
Potassium chloride 3 [hp_x]/ml
Potassium phosphate, dibasic 3 [hp_x]/ml
Plantago major 3 [hp_x]/ml
Selenicereus grandiflorus stem 5 [hp_x]/ml
Digitalis 6 [hp_x]/ml
Beef heart 6 [hp_x]/ml
Levocarnitine 6 [hp_x]/ml
Valine 6 [hp_x]/ml
Sus scrofa thyroid 6 [hp_x]/ml
Artemisia abrotanum flowering top 12 [hp_x]/ml
Iodine 12 [hp_x]/ml
Egg phospholipids 12 [hp_x]/ml
Spigelia anthelmia 12 [hp_x]/ml
Route ORAL
Dosage Form LIQUID
Labeler Name BioActive Nutritional, Inc.
Packages
Package NDC Code Description
43857-0073-1 30 ml in 1 bottle, dropper (43857-0073-1)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS: Kali Muriaticum 3X, Kali Phosphoricum 3X, Plantago Major 3X, Cactus Grandiflorus 5X, Digitalis Purpurea 6X, Heart (Bovine) 6X, L-Carnitine 6X, L-Valine 6X, Thyroidinum (Suis) 6X, Abrotanum (Artemisia Abrotanum) 12X, Iodium 12X, Lecithin 12X, Spigelia Anthelmia 12X.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Acacia Gum, Borage Oil, Demineralized Water, 25% Ethanol, Flax Seed Oil

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS: For temporary relief of nervous anxiety with tiredness, difficulty breathing at night while sleeping, coldness of hands & feet, swelling of extremities.

Purpose

Information about the drug product’s indications for use.
INDICATIONS: For temporary relief of nervous anxiety with tiredness, difficulty breathing at night while sleeping, coldness of hands & feet, swelling of extremities.

Spl product data elements

Usually a list of ingredients in a drug product.
Cardio Tonic Kali Muriaticum, Kali Phosphoricum, Plantago Major, Cactus Grandiflorus, Digitalis Purpurea, Heart (Bovine), L-Carnitine, L-Valine, Thyroidinum (Suis), Abrotanum (Artemisia Abrotanum), Iodium, Lecithin, Spigelia Anthelmia POTASSIUM CHLORIDE POTASSIUM CATION POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION PLANTAGO MAJOR PLANTAGO MAJOR SELENICEREUS GRANDIFLORUS STEM SELENICEREUS GRANDIFLORUS STEM DIGITALIS DIGITALIS BEEF HEART BEEF HEART LEVOCARNITINE LEVOCARNITINE VALINE VALINE SUS SCROFA THYROID SUS SCROFA THYROID ARTEMISIA ABROTANUM FLOWERING TOP ARTEMISIA ABROTANUM FLOWERING TOP IODINE IODINE EGG PHOSPHOLIPIDS EGG PHOSPHOLIPIDS SPIGELIA ANTHELMIA SPIGELIA ANTHELMIA BORAGE OIL LINSEED OIL ACACIA WATER ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL DISPLAY: BIO Active Nutritional CARDIO TONIC HOMEOPATHIC 1 FL OZ (30 ml) Cardio Tonic

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API