Menopause Plus Bladder
Lytta Vesicatoria,caulophyllum Thalictroides Root,equisetum Hyemale,anemone Pulsatilla,rhus Aromatica Root Bark,atropa Belladonna,sulfur,sepia Officinalis Juice,black Cohosh And Lachesis Muta Venom
Hyland's Inc.
Human Otc Drug
NDC 54973-3361Menopause Plus Bladder also known as Lytta Vesicatoria,caulophyllum Thalictroides Root,equisetum Hyemale,anemone Pulsatilla,rhus Aromatica Root Bark,atropa Belladonna,sulfur,sepia Officinalis Juice,black Cohosh And Lachesis Muta Venom is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Menopause Plus Bladder is 54973-3361. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Menopause Plus Bladder drug includes Anemone Pulsatilla - 12 [hp_X]/1 Atropa Belladonna - 12 [hp_X]/1 Black Cohosh - 12 [hp_X]/1 Caulophyllum Thalictroides Root - 12 [hp_X]/1 Equisetum Hyemale - 6 [hp_X]/1 Lachesis Muta Venom - 30 [hp_X]/1 Lytta Vesicatoria - 6 [hp_X]/1 Rhus Aromatica Root Bark - 6 [hp_X]/1 Sepia Officinalis Juice - 12 [hp_X]/1 Sulfur - 12 [hp_X]/1 . The currest status of Menopause Plus Bladder drug is Active.
Drug Information:
| Drug NDC: | 54973-3361 |
| 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: | Menopause Plus Bladder |
| 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: | Lytta Vesicatoria,caulophyllum Thalictroides Root,equisetum Hyemale,anemone Pulsatilla,rhus Aromatica Root Bark,atropa Belladonna,sulfur,sepia Officinalis Juice,black Cohosh And Lachesis Muta Venom |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hyland's Inc. |
| 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: | ANEMONE PULSATILLA - 12 [hp_X]/1
ATROPA BELLADONNA - 12 [hp_X]/1
BLACK COHOSH - 12 [hp_X]/1
CAULOPHYLLUM THALICTROIDES ROOT - 12 [hp_X]/1
EQUISETUM HYEMALE - 6 [hp_X]/1
LACHESIS MUTA VENOM - 30 [hp_X]/1
LYTTA VESICATORIA - 6 [hp_X]/1
RHUS AROMATICA ROOT BARK - 6 [hp_X]/1
SEPIA OFFICINALIS JUICE - 12 [hp_X]/1
SULFUR - 12 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | SUBLINGUAL
|
| 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: | 01 Jun, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | Hyland's 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. |
| UNII: | I76KB35JEV
WQZ3G9PF0H
K73E24S6X9
JTJ6HH6YEH
59677RXH25
VSW71SS07I
3Q034RO3BT
Q3H36W0J42
QDL83WN8C2
70FD1KFU70
|
| 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 |
|---|
| 54973-3361-3 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3361-3) / 60 TABLET in 1 BOTTLE, PLASTIC | 01 Jun, 2018 | 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:
Active ingredients purpose belladonna 12x hpus hot flashes, night sweats cantharis 6x hpus symptoms of overactive bladder caulophyllum 12x hpus irritability cimicifuga racemosa 12x hpus hot flashes equisetum hyemale 6x hpus symptoms of overactive bladder lachesis 30x hpus hot flashes pulsatilla 12x hpus hot flashes, night sweats rhus aromatica 6x hpus symptoms of overactive bladder sepia officinalis 12x hpus irritability, hot flashes, night sweats sulphur 12x hpus hot flashes, night sweats âhpusâ indicates that the active ingredients are in the official homeopathic pharmacopÅia of the united states.
Product Elements:
Menopause plus bladder lytta vesicatoria,caulophyllum thalictroides root,equisetum hyemale,anemone pulsatilla,rhus aromatica root bark,atropa belladonna,sulfur,sepia officinalis juice,black cohosh and lachesis muta venom lactose monohydrate anhydrous lactose acacia black cohosh black cohosh atropa belladonna atropa belladonna sepia officinalis juice sepia officinalis juice lachesis muta venom lachesis muta venom lytta vesicatoria lytta vesicatoria caulophyllum thalictroides root caulophyllum thalictroides root equisetum hyemale equisetum hyemale anemone pulsatilla anemone pulsatilla rhus aromatica root bark rhus aromatica root bark sulfur sulfur off-white to white
Indications and Usage:
Uses temporarily relieves the symptoms of overactive bladder, irritability, hot flashes, and night sweats experienced during menopause. you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ⢠urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours). ⢠urinary urgency (a strong need to urinate right away). ⢠urinary incontinence (leaking or wetting yourself if you cannot control the urge to urinate).
Warnings:
Warnings frequent urination can also be caused by: ⢠urinary tract infections (uti). ï® â¢ diabetes. ï® â¢ early pregnancy. ï® â¢ other more serious conditions. if you think you might have one of these conditions, it is important to see your doctor before use. as with any drug, ask a doctor before use if pregnant or breast-feeding. do not use: ï® â¢ more than directed. ï® â¢ if you have a known allergy to any ingredient in this product. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately.
Do Not Use:
Warnings frequent urination can also be caused by: ⢠urinary tract infections (uti). ï® â¢ diabetes. ï® â¢ early pregnancy. ï® â¢ other more serious conditions. if you think you might have one of these conditions, it is important to see your doctor before use. as with any drug, ask a doctor before use if pregnant or breast-feeding. do not use: ï® â¢ more than directed. ï® â¢ if you have a known allergy to any ingredient in this product. consult a physician if symptoms persist for more than 7 days or worsen. keep this and all medications out of reach of children. in case of accidental overdose, contact a medical professional or poison control center immediately.
Dosage and Administration:
Directions adults: take two tablets at onset of symptoms and repeat every four hours as needed.
Package Label Principal Display Panel:
Principal display panel - menopause+ bladder ndc 54973-3361-3 doctor wise homeopathy menopause+ bladder natural relief of overactive bladder, hot flashes & night sweats* soy free 68 sublingual tablets includes two 4-tablet sachets label
Further Questions:
Questions or comments? (800) 624-9659