Cheeky Bonsai Uti Pain Relief
Phenazopyridine Hydrochloride
Ixxa, Inc
Human Otc Drug
NDC 81860-113Cheeky Bonsai Uti Pain Relief also known as Phenazopyridine Hydrochloride is a human otc drug labeled by 'Ixxa, Inc'. National Drug Code (NDC) number for Cheeky Bonsai Uti Pain Relief is 81860-113. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cheeky Bonsai Uti Pain Relief drug includes Phenazopyridine Hydrochloride - 99.5 mg/1 . The currest status of Cheeky Bonsai Uti Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 81860-113 |
| 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: | Cheeky Bonsai Uti Pain Relief |
| 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: | Phenazopyridine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ixxa, 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: | PHENAZOPYRIDINE HYDROCHLORIDE - 99.5 mg/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 DRUG OTHER |
| 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: | 12 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | IXXA, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094147
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0EWG668W17
|
| 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 |
|---|
| 81860-113-24 | 1 BLISTER PACK in 1 CARTON (81860-113-24) / 24 TABLET in 1 BLISTER PACK | 12 May, 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 urinary analgesic
Product Elements:
Cheeky bonsai uti pain relief phenazopyridine hydrochloride phenazopyridine hydrochloride phenazopyridine lactose starch, corn croscarmellose sodium hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a corn talc triacetin p99
Indications and Usage:
Use fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Warnings:
Warnings do not exceed recommended dosage do not use if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your physician
When Using:
When using this product â stomach upset may occur, taking this product with or after meals may reduce stomach upset â your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items.
Dosage and Administration:
Directions â adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed â children under 12 years: consult a doctor â do not use for more than 2 days (12 tablets) without consulting a doctor image of carton
Stop Use:
Stop use and ask doctor if â your symptoms last for more than 2 days â you suspect you are having an adverse reaction to the medication long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Package Label Principal Display Panel: