Simply Harmony

Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis, Kali Phosphoricum

Nartex Laboratorios Homeopaticos, S.a. De C.v.
Human Otc Drug
NDC 34666-403

Simply Harmony also known as Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis, Kali Phosphoricum is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos, S.a. De C.v.'. National Drug Code (NDC) number for Simply Harmony is 34666-403. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Simply Harmony drug includes Dibasic Potassium Phosphate - 6 [hp_X]/1 Passiflora Incarnata Flowering Top - 3 [hp_X]/1 Strychnos Ignatii Seed - 3 [hp_X]/1 Valerian - 3 [hp_X]/1 . The currest status of Simply Harmony drug is Active.

Drug Information:

Drug NDC:	34666-403
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:	Simply Harmony
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:	Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis, Kali Phosphoricum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Nartex Laboratorios Homeopaticos, S.a. De C.v.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	DIBASIC POTASSIUM PHOSPHATE - 6 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP - 3 [hp_X]/1 STRYCHNOS IGNATII SEED - 3 [hp_X]/1 VALERIAN - 3 [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:	03 Dec, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
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:	31 Dec, 2023
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:	Nartex Laboratorios Homeopaticos, S.A. De C.V.
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.
UPC:	0844827001402
UPC stands for Universal Product Code.
UNII:	CI71S98N1Z CLF5YFS11O 1NM3M2487K JWF5YAW3QW
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
34666-403-01	1 BOTTLE in 1 CARTON (34666-403-01) / 120 TABLET in 1 BOTTLE	03 Dec, 2021	N/A	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

Simply Harmony

Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis, Kali Phosphoricum

Tablet
Nartex Laboratorios Homeopaticos, S.A. De C.V.
NDC: 34666-403

Purpose:

Purpose ignatia amara 3x hpus*.................................headache, mental fatigue and insomnia from emotional disorders passiflora incarnata 3x hpus*........................sleeplessness from worries and restlessness valeriana officinalis 3x hpus*........................restless sleep kali phosphoricum 6x hpus*.........................mental fatigue, difficulty concentrating, headaches, occasional sleeplessness *the letters "hpus" indicate that the compoennts in this product are officially monographed in the homeopathic pharmacopoeia of the united states. "x" is a homeopathic dilution. see www.nartexlabsusa.com for more information.

Product Elements:

Simply harmony ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum lactose, unspecified form starch, potato talc passiflora incarnata flowering top passiflora incarnata flowering top water sodium benzoate valerian valerian dibasic potassium phosphate phosphate ion gelatin magnesium stearate strychnos ignatii seed strychnos ignatii seed logonartex

Indications and Usage:

Uses for the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. for hard-day periods. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by fda, and product has not been clinically tested.

Warnings:

Warnings do not use if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product. stop use and ask a doctor if conditoin worsens. symptoms persist for more than 7 days or clear up and occur again within a few days. rash develops. if pregnant or breast feeding, consult a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

Dosage and Administration:

Directions adults and children 12 years and older: take 1 tablet every 8 hours. dissolves slowly in mouth. children under 12 years, consult a physician.

Stop Use:

Stop use and ask a doctor if conditoin worsens. symptoms persist for more than 7 days or clear up and occur again within a few days. rash develops.

Package Label Principal Display Panel:

Ndc 34666-403-01 simply harmony mental fatigue relief stay calm stay sharp stay focused mood support claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated and not clinically tested. homeopathic 120 tablets 1 2

Further Questions:

Questions or comments? informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm cst. active ingredients are prepared in accordance with the homeopathic pharmacopoeia of the united states, and are therefore non-toxic and have no known side effects.

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.