NDC 43857-0488 Headache

Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis

NDC Product Code 43857-0488

NDC CODE: 43857-0488

Proprietary Name: Headache 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: Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

NDC Code Structure

  • 43857 - Bioactive Nutritionals, Inc.

NDC 43857-0488-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Headache with NDC 43857-0488 is a a human over the counter drug product labeled by Bioactive Nutritionals, Inc.. The generic name of Headache is melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritionals, 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.

Headache 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.

  • MELILOTUS OFFICINALIS TOP 3 [hp_X]/mL
  • SPIGELIA ANTHELMIA 6 [hp_X]/mL
  • ONION 12 [hp_X]/mL
  • ATROPA BELLADONNA 12 [hp_X]/mL
  • BRYONIA ALBA ROOT 12 [hp_X]/mL
  • BLACK COHOSH 12 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X]/mL
  • NITROGLYCERIN 12 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 12 [hp_X]/mL
  • SILICON DIOXIDE 12 [hp_X]/mL
  • CITHARACANTHUS SPINICRUS 12 [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: Bioactive Nutritionals, Inc.
Labeler Code: 43857
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: 07-19-2018 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.

Headache Product Label Images

Headache 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 Ingredients:

Melilotus Officinalis 9X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.

Indications:

For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

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 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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalHEADACHEHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.