Simply Shift
Passiflora Incarnata, Valeriana Officinalis, Arnica Montana
Nartex Laboratorios Homeopaticos, S.a. De C.v.
Human Otc Drug
NDC 34666-404Simply Shift also known as Passiflora Incarnata, Valeriana Officinalis, Arnica Montana is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos, S.a. De C.v.'. National Drug Code (NDC) number for Simply Shift is 34666-404. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Simply Shift drug includes Arnica Montana - 12 [hp_X]/1 Passiflora Incarnata Flowering Top - 1 [hp_X]/1 Valerian - 1 [hp_X]/1 . The currest status of Simply Shift drug is Active.
Drug Information:
| Drug NDC: | 34666-404 |
| 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 Shift |
| 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: | Passiflora Incarnata, Valeriana Officinalis, Arnica Montana |
| 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: | ARNICA MONTANA - 12 [hp_X]/1
PASSIFLORA INCARNATA FLOWERING TOP - 1 [hp_X]/1
VALERIAN - 1 [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: | 07 May, 2026 |
| 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: | 0844827001426
|
| UPC stands for Universal Product Code. |
| UNII: | O80TY208ZW
CLF5YFS11O
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 |
|---|
| 34666-404-01 | 1 BOTTLE in 1 CARTON (34666-404-01) / 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. |
Purpose:
Purpose passiflora incarnata 1x hpus*......................sleeplessness from worries and restlessness valeriana officinalis 1x hpus*.......................restless sleep arnica montana 12x hpus*...........................fatigue *the letters "hpus" indicate that the compoentns 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 shift passiflora incarnata, valeriana officinalis, arnica montana arnica montana arnica montana magnesium stearate sodium benzoate gelatin lactose, unspecified form valerian valerian water talc starch, potato passiflora incarnata flowering top passiflora incarnata flowering top logonartex
Indications and Usage:
Uses for the temporary relief of fatigue and lethargy and the restoration of a natural sleep pattern disturbed by long commutes, night shifts, travel or jet lag. 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 if sleeplessness persists continuously for more than 2 weeks, consult your doctor. insomnia may be a symptom of serious underlining medical illness. do not take this product for pain for more than 10 days unless directed by a doctor. if pain persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. do not use if you have an allergy or hypersensitivity to the componetns of the formula or have had a prior reaction to this product. stop use and ask a doctor if condition 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:
Warnings if sleeplessness persists continuously for more than 2 weeks, consult your doctor. insomnia may be a symptom of serious underlining medical illness. do not take this product for pain for more than 10 days unless directed by a doctor. if pain persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. do not use if you have an allergy or hypersensitivity to the componetns of the formula or have had a prior reaction to this product. stop use and ask a doctor if condition 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.
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 condition 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 34666-404-01 simply shift sleep cycle restoration associated to long commutes, night shifts, travel or jet lag feel refreshed and rested stay calm reduce fatigue and lethargy claims based on traditional homeopathic practice, not accepted medical evidence. not fda evalluated and not clinically tested. homeopathic nighttime sleep aid 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.