NDC 61727-353 Bladder Irritation And Uti

Cantharis, Clematis, Cubeba, Echinacea, Ranunculus Bulbosus, Sabal Ser, Staphysagria, Uva Ursi

NDC Product Code 61727-353

NDC Code: 61727-353

Proprietary Name: Bladder Irritation And Uti 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: Cantharis, Clematis, Cubeba, Echinacea, Ranunculus Bulbosus, Sabal Ser, Staphysagria, Uva Ursi 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
10 MM
Score: 1

NDC Code Structure

  • 61727 - Homeocare Laboratories, Inc.
    • 61727-353 - Bladder Irritation And Uti

NDC 61727-353-60

Package Description: 60 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Bladder Irritation And Uti with NDC 61727-353 is a a human over the counter drug product labeled by Homeocare Laboratories, Inc.. The generic name of Bladder Irritation And Uti is cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal ser, staphysagria, uva ursi. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Homeocare Laboratories, Inc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Bladder Irritation And Uti 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.

  • SERENOA REPENS WHOLE 6 [hp_X]/601
  • PIPER CUBEBA FRUIT 6 [hp_X]/601
  • CLEMATIS RECTA FLOWERING TOP 6 [hp_X]/601
  • ARCTOSTAPHYLOS UVA-URSI LEAF 6 [hp_X]/601
  • DELPHINIUM STAPHISAGRIA SEED 6 [hp_X]/601
  • ECHINACEA ANGUSTIFOLIA 6 [hp_X]/601
  • LYTTA VESICATORIA 6 [hp_X]/601
  • RANUNCULUS BULBOSUS 6 [hp_X]/601

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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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: Homeocare Laboratories, Inc.
Labeler Code: 61727
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: 03-19-2019 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.

Bladder Irritation And Uti Product Label Images

Bladder Irritation And Uti 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

Uses*

  • Temporarily relievesburning sensationfrequent urge to urinatepainful urinationinflammation

  • Temporarily relievesburning sensationfrequent urge to urinatepainful urinationinflammation

Directions:

Adult and children 12 years and older: Under 12 consult a doctor. Slightly chew one tablet and allow to dissolve in the mouth, 3 times daily or up to 6 times daily for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve. Take at least 15mn apart from food and drinks

Warnings

If pregnant or breastfeeding, ask a health professional before use.
Stop use and ask a doctor if symptoms persist, worsen or reoccur, are severe, or if you experience fever, chills, back pain or bloody urine.
Keep this and all medicinces out of the reach of children.

Inactive Ingredients:

Lactose, dextrose, croscarmellose sodium, microcrystalline cellulose, magnesium stearate.

Drug Facts Active Ingredients Hpus Purpose

Each 300-mg tablet contains equal parts ofCantharis 6X......Bladder and urethra inflammationClematis 6X......Milky urine, burning sensationCubeba 6X......Blood in urineEchinacea 6X......Pain and burning on urinationRanunculus bulbosus 6X......Frequent urging to urinateSabal ser. 6X......Painful urination, scalding urineStaphysagria 6X......Burning sensation in urethraUva ursi 6X......Painful urination, urging

* Please review the disclaimer below.

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