All-in-one Uti Emergency Kit
Methenamine, Sodium Salicylate, And Phenazopyridine Hydrochloride
Uqora Inc
Human Otc Drug
NDC 73712-500All-in-one Uti Emergency Kit also known as Methenamine, Sodium Salicylate, And Phenazopyridine Hydrochloride is a human otc drug labeled by 'Uqora Inc'. National Drug Code (NDC) number for All-in-one Uti Emergency Kit is 73712-500. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in All-in-one Uti Emergency Kit drug includes . The currest status of All-in-one Uti Emergency Kit drug is Active.
Drug Information:
| Drug NDC: | 73712-500 |
| 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: | All-in-one Uti Emergency Kit |
| 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: | Methenamine, Sodium Salicylate, And Phenazopyridine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Uqora Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 17 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 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: | UQORA INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094147
1489932
|
| 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: | |
| 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 |
|---|
| 73712-500-24 | 1 KIT in 1 CARTON (73712-500-24) * 12 TABLET in 1 BLISTER PACK (73712-804-12) * 12 TABLET in 1 BLISTER PACK (73712-113-12) | 17 Oct, 2022 | 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 (in each tablet) purpose methenamine 162mg antibacterial sodium salicylate 162.5mg (nsaid)* *nonsteroidal anti-inflammatory drug analgesic (pain reliever) active ingredient (in each tablet) purpose phenazopyridine hydrochloride 99.5mg urinary tract analgesic
Product Elements:
All-in-one uti emergency kit methenamine, sodium salicylate, and phenazopyridine hydrochloride uqora antibacterial plus urinary pain relief methenamine, sodium salicylate sodium bicarbonate triethyl citrate methenamine methenamine fd&c yellow no. 6 hypromelloses fd&c red no. 40 sodium salicylate salicylic acid benzoic acid croscarmellose sodium magnesium stearate methacrylic acid-ethyl acrylate copolymer (1:1) type a cellulose, microcrystalline silicon dioxide stearic acid sodium lauryl sulfate talc titanium dioxide triacetin ph061 uqora maximum strength urinary pain relief phenazopyridine hydrochloride polyethylene glycol, unspecified cellulose, microcrystalline phenazopyridine hydrochloride phenazopyridine hypromelloses magnesium stearate silicon dioxide sodium starch glycolate type a croscarmellose sodium lactose, unspecified form povidone, unspecified talc triacetin starch, corn p99
Indications and Usage:
Uses uti infection control temporarily relieves: pain and burning frequency and urgency of urination uti pain relief fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. treatment should not exceed 2 days; see directions.
Warnings:
Warnings reye's syndrome (uti infection control only) reyeâs syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reyeâs syndrome, a rare but serious illness. stomach bleeding warning (uti infection control only) stomach bleeding warning: this product contains a nonsteroidal anti-inflammatory drug (nsaid), which may cause stomach bleeding. the chance is higher if you are 60 or older have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an nsaid (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not exceed (uti pain relief only) do not exceed recommended dosage do not use do not use : if y
Read more...ou are allergic to salicylates (including aspirin) ( uti infection control only ) if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your doctor ( uti pain relief only) ask a doctor before use ask a doctor before use if you have: frequent, burning urination for the first time (uti infection control only) the stomach bleeding warning applying to you (uti infection control only) history of stomach problems, such as heartburn (uti infection control only) high blood pressure (uti infection control only) heart disease (uti infection control only) liver cirrhosis (uti infection control only) bleeding problems (uti infection control only) diuretic use (uti infection control only) ulcers (uti infection control only) kidney disease a sodium restricted diect (uti infection control only) reached age 60 or older (uti infection control only) allergies to foods, preservatives or dyes (uti pain relief only) had a hypersensitive reaction to phenazopyridine (uti pain relief only) ask a doctor or pharmacist before use (uti infection control only) ask a doctor or pharmacist before use if you are: taking any other drug containing an nsaid (prescription or non-prescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug when using this product when using this product: do not take more than the recommended dosage (uti infection control only) stomach upset may occur, taking this product with or after meals may reduce stomach upset (uti pain relief only) your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items. (uti pain relief only) stop use and ask a doctor stop use and ask a doctor if : product has been used for 3 days (uti infection control only) ringing in the ears (uti infection control only) you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stool â have stomach pain or upset that gets worse or lasts (uti infection control only) your symptoms last for more than 2 days (uti pain relief only) you suspect you are having an adverse reaction to the medication (uti pain relief only) long term administration (uti pain relief only) 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. if pregnant or breast feeding uti infection control if pregnant or breast feeding, ask a health professional before use. it is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. uti pain relief if pregnant or breast feeding, ask a health professional before use. keep out of the reach of children keep out of the reach of children. in case of overdose, get medical help or contact a poison control center right away 1-800-222-1222
Do Not Use:
Warnings reye's syndrome (uti infection control only) reyeâs syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reyeâs syndrome, a rare but serious illness. stomach bleeding warning (uti infection control only) stomach bleeding warning: this product contains a nonsteroidal anti-inflammatory drug (nsaid), which may cause stomach bleeding. the chance is higher if you are 60 or older have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an nsaid (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not exceed (uti pain relief only) do not exceed recommended dosage do not use do not use : if you are allergic to salicylates (including aspirin) ( uti infection control only ) if you have glucose-6-phosphate dehydrogenase (g6pd) deficiency unless approved by your doctor ( uti pain relief only) ask a doctor before use ask a doctor before use if you have: frequent, burning urination for the first time (uti infection control only) the stomach bleeding warning applying to you (uti infection control only) history of stomach problems, such as heartburn (uti infection control only) high blood pressure (uti infection control only) heart disease (uti infection control only) liver cirrhosis (uti infection control only) bleeding problems (uti infection control only) diuretic use (uti infection control only) ulcers (uti infection control only) kidney disease a sodium restricted diect (uti infection control only) reached age 60 or older (uti infection control only) allergies to foods, preservatives or dyes (uti pain relief only) had a hypersensitive reaction to phenazopyridine (uti pain relief only) ask a doctor or pharmacist before use (uti infection control only) ask a doctor or pharmacist before use if you are: taking any other drug containing an nsaid (prescription or non-prescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug when using this product when using this product: do not take more than the recommended dosage (uti infection control only) stomach upset may occur, taking this product with or after meals may reduce stomach upset (uti pain relief only) your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items. (uti pain relief only) stop use and ask a doctor stop use and ask a doctor if : product has been used for 3 days (uti infection control only) ringing in the ears (uti infection control only) you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stool â have stomach pain or upset that gets worse or lasts (uti infection control only) your symptoms last for more than 2 days (uti pain relief only) you suspect you are having an adverse reaction to the medication (uti pain relief only) long term administration (uti pain relief only) 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. if pregnant or breast feeding uti infection control if pregnant or breast feeding, ask a health professional before use. it is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. uti pain relief if pregnant or breast feeding, ask a health professional before use. keep out of the reach of children keep out of the reach of children. in case of overdose, get medical help or contact a poison control center right away 1-800-222-1222
When Using:
When using this product when using this product: do not take more than the recommended dosage (uti infection control only) stomach upset may occur, taking this product with or after meals may reduce stomach upset (uti pain relief only) your urine will become reddish-orange in color. this is not harmful, but care should be taken to avoid staining clothing or other items. (uti pain relief only)
Dosage and Administration:
Directions uti infection control adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. drink plenty of fluids. do not use for more than a 3 day period unless directed by a doctor. children under 12 years : ask a doctor. uti pain relief 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 do not use for more than 2 days (12 tablets) without consulting a doctor. children under 12 years: consult a doctor
Stop Use:
Stop use and ask a doctor stop use and ask a doctor if : product has been used for 3 days (uti infection control only) ringing in the ears (uti infection control only) you experience any of the following signs of stomach bleeding: â feel faint â vomit blood â have bloody or black stool â have stomach pain or upset that gets worse or lasts (uti infection control only) your symptoms last for more than 2 days (uti pain relief only) you suspect you are having an adverse reaction to the medication (uti pain relief only)
Package Label Principal Display Panel:
Principal display panel uqora urinary care 3-in-1 convenience kit all-in-one uti emergency kit 2 day supply includes: test strips test for a possible uti at home in 2 minutes 2 tests infection control help manage a uti & slow infection progress 12 tablets (methenamine & sodium salicylate (nsaid) pain relief quickly sooth uti pain & burning to feel relief 12 tablets (99.5mg phenazopyridine hydrochloride) packaged for convenience. not intended to replace medical care. emergency kit carton
Further Questions:
Distributed by uqora, inc. 3043 4th avenue, san diego, ca 92103 support@uqora.com for questions or concerns please contact (888) 313-1372