NDC 55146-003 3 Acute Stress

Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria

NDC Product Code 55146-003

NDC Code: 55146-003

Proprietary Name: 3 Acute Stress 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: Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria 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

  • 55146 - Biotics Research Corporation
    • 55146-003 - 3 Acute Stress

NDC 55146-003-01

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC Product Information

3 Acute Stress with NDC 55146-003 is a a human over the counter drug product labeled by Biotics Research Corporation. The generic name of 3 Acute Stress is arnica montana, bellis perennis, passiflora incarnata, valeriana officinalis, arsenicum album, apis mellifica, carcinosin, cistus canadensis, clematis erecta, coffea cruda, ignatia amara, lachesis mutus, magnesia phosphorica, natrum muriaticum, natrum sulphuricum, ornithogalum umbellatum, phosphoricum acidum, salix nigra, staphysagria. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Biotics Research Corporation

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.

3 Acute Stress 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.

  • ARNICA MONTANA 3 [hp_X]/mL
  • BELLIS PERENNIS 3 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]/mL
  • VALERIAN 3 [hp_X]/mL
  • ARSENIC TRIOXIDE 6 [hp_X]/mL
  • APIS MELLIFERA 30 [hp_C]/mL
  • HUMAN BREAST TUMOR CELL 30 [hp_C]/mL
  • HELIANTHEMUM CANADENSE 30 [hp_C]/mL
  • CLEMATIS RECTA FLOWERING TOP 30 [hp_C]/mL
  • ARABICA COFFEE BEAN 30 [hp_C]/mL
  • STRYCHNOS IGNATII SEED 30 [hp_C]/mL
  • LACHESIS MUTA VENOM 30 [hp_C]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_C]/mL
  • SODIUM CHLORIDE 30 [hp_C]/mL
  • SODIUM SULFATE 30 [hp_C]/mL
  • ORNITHOGALUM UMBELLATUM 30 [hp_C]/mL
  • PHOSPHORIC ACID 30 [hp_C]/mL
  • SALIX NIGRA BARK 30 [hp_C]/mL
  • DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • 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.

Product Labeler Information

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

Labeler Name: Biotics Research Corporation
Labeler Code: 55146
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: 06-11-2019 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.

3 Acute Stress Product Label Images

3 Acute Stress 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:

Arnica Montana 3X, 30C, Bellis Perennis 3X, 30C, Passiflora Incarnata 3X, 30C, Valeriana Officinalis 3X, 30C, Arsenicum Album 6X, 30C, Apis Mellifica 30C, Carcinosin 30C, Cistus Canadensis 30C, Clematis Erecta 30C, Coffea Cruda 30C, Ignatia Amara 30C, Lachesis Mutus 30C, Magnesia Phosphorica 30C, Natrum Muriaticum 30C, Natrum Sulphuricum 30C, Ornithogalum Umbellatum 30C, Phosphoricum Acidum 30C, Salix Nigra 30C, Staphysagria 30C.

Indications:

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

Warnings:

If symptoms persist or worsen, seek the advice of a healthcare professional.Caution: Not recommended for pregnant or lactating women.KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center right away.Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

Keep Out Of Reach Of Children:

KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional.Consult a physician for use in children under 6 years of age.

Inactive Ingredients:

Citric Acid, Demineralized Water, Ethanol 1.65%, Sodium Benzoate.

Questions:

Distributed byBiotics Research CorporationRosenberg, TX 77471 • (281) 344-0909

Package Label Display:

Biotics Research Corporation's21ST CENTURYHOMEOPATHICSNDC# 55146-003-01HOMEOPATHIC REMEDY#3Acute StressWater BasedFormula4 fl. oz.(120 ml)

* Please review the disclaimer below.

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