Wellness Earache

Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)

Source Naturals, Inc.
Human Otc Drug
NDC 64471-126

Wellness Earache also known as Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis) is a human otc drug labeled by 'Source Naturals, Inc.'. National Drug Code (NDC) number for Wellness Earache is 64471-126. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Wellness Earache drug includes Aconitum Napellus - 30 [hp_X]/1 Capsicum - 6 [hp_X]/1 Ferrum Phosphoricum - 12 [hp_X]/1 Oyster Shell Calcium Carbonate, Crude - 30 [hp_X]/1 Potassium Chloride - 12 [hp_X]/1 Pulsatilla Pratensis - 30 [hp_X]/1 Silicon Dioxide - 6 [hp_X]/1 Verbascum Thapsus - 6 [hp_X]/1 . The currest status of Wellness Earache drug is Active.

Drug Information:

Drug NDC:	64471-126
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Wellness Earache
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Source Naturals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Chewable
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACONITUM NAPELLUS - 30 [hp_X]/1 CAPSICUM - 6 [hp_X]/1 FERRUM PHOSPHORICUM - 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE - 30 [hp_X]/1 POTASSIUM CHLORIDE - 12 [hp_X]/1 PULSATILLA PRATENSIS - 30 [hp_X]/1 SILICON DIOXIDE - 6 [hp_X]/1 VERBASCUM THAPSUS - 6 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	13 Jun, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 Nov, 2023
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	10 Jun, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Source Naturals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	U0NQ8555JD 00UK7646FG 91GQH8I5F7 2E32821G6I 660YQ98I10 8E272251DI ETJ7Z6XBU4 C9TD27U172
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Potassium Compounds [CS] Potassium Salt [EPC] Vegetable Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64471-126-48	2 BLISTER PACK in 1 CARTON (64471-126-48) / 24 TABLET, CHEWABLE in 1 BLISTER PACK	13 Jun, 2018	30 Nov, 2023	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Wellness Earache

Capsicum Annuum & more..

Tablet, Chewable
Source Naturals, Inc.
NDC: 64471-126

Purpose:

Indications: for the temporary relief of ear pain, blockage, ear inflammation, irritability and fever associated with earaches. claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. store in a cool, dry place.

Product Elements:

Wellness earache capsicum annuum, silicea, verbascum thapsus, ferrum phosphoricum, kali muriaticum, aconitum napellus, belladonna, calcarea carbonica, pulsatilla (pratensis) capsicum capsicum silicon dioxide silicon dioxide verbascum thapsus verbascum thapsus ferrum phosphoricum ferrosoferric phosphate potassium chloride potassium cation aconitum napellus aconitum napellus oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude pulsatilla pratensis pulsatilla pratensis lactose monohydrate magnesium stearate h

Indications and Usage:

Warnings:

Warnings: in case of overdose, get medical help or contact a poison control center right away. a high fever may be the sign of a serious health condition. if fever or ear pain persist for more than 2 days or new symptoms occur, consult a physician. as with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a physician before using this product. keep this and all medicines out of the reach of children. tamper evident: do not use if foil blister backing is broken. foil backing is printed with product name and lot number. contains milk.

Dosage and Administration:

Directions: chew 1 tablet slightly and let it dissolve in the mouth. for infants, crush a tablet between two spoons, add water or juice if desired, and place in mouth. repeat every 2 to 4 hours as needed, for up to 48 hours. for optimal results take 3-4 doses per day. one or two doses per day may be taken for up to 4 weeks if symptoms recur or do not resolve completely. give wellness earache to children or infants over 6 months of age. this product is not recommended for use by infants under 6 months of age without the advice of your physician. for best results: keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. these substances may interfere with absorption.

Package Label Principal Display Panel:

Package label display: source naturals with painsoothe homeopathic children's formula wellness earache pain â¢ blockage â¢ inflammation â¢ irritability â¢ fever 48 homeopathic tablets wellness earache ctn front wellness earache ctn back

Further Questions:

Questions: source naturals, inc. p.o. box 2118 santa cruz, ca. usa 95062 www.sourcenaturals.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.