Azo Urinary Tract Defense Antibacterial Protection
Methenamine, Sodium Salicylate
I-health, Inc.
Human Otc Drug
NDC 49973-011Azo Urinary Tract Defense Antibacterial Protection also known as Methenamine, Sodium Salicylate is a human otc drug labeled by 'I-health, Inc.'. National Drug Code (NDC) number for Azo Urinary Tract Defense Antibacterial Protection is 49973-011. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Azo Urinary Tract Defense Antibacterial Protection drug includes Methenamine - 162 mg/1 Sodium Salicylate - 162.5 mg/1 . The currest status of Azo Urinary Tract Defense Antibacterial Protection drug is Active.
Drug Information:
| Drug NDC: | 49973-011 |
| 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: | Azo Urinary Tract Defense Antibacterial Protection |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Azo Urinary Tract Defense |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Antibacterial Protection |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | I-health, 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: | METHENAMINE - 162 mg/1
SODIUM SALICYLATE - 162.5 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: | 06 Nov, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | i-Health, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1489932
1721434
|
| 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: | J50OIX95QV
WIQ1H85SYP
|
| 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 |
|---|
| 49973-011-18 | 1 BLISTER PACK in 1 BOX (49973-011-18) / 18 TABLET in 1 BLISTER PACK | 23 Apr, 2018 | N/A | No |
| 49973-011-24 | 1 BLISTER PACK in 1 BOX (49973-011-24) / 24 TABLET in 1 BLISTER PACK | 01 Mar, 2016 | 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 antibacterial analgesic (pain reliever)
Product Elements:
Azo urinary tract defense antibacterial protection methenamine, sodium salicylate methenamine methenamine sodium salicylate salicylic acid benzoic acid powdered cellulose croscarmellose sodium ferrosoferric oxide fd&c red no. 40 fd&c yellow no. 6 hydroxypropyl cellulose (1600000 wamw) hypromelloses magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a silicon dioxide stearic acid titanium dioxide triethyl citrate azoud
Indications and Usage:
Uses temporarily relieves: pain & burning frequency and urgency of urination
Warnings:
Warnings reye's syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. stomach bleeding warning: this product contains an nsaid, which may cause stomach bleeding. the chance is higher if you: take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take more or for a longer time than directed do not use: if you are on a sodium restricted diet if you are allergic to salicylates (including aspirin) unless directed by a doctor if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recu
Read more...r, or if you have ulcers or bleeding problems unless directed by a doctor ask a doctor before use if you have frequent, burning urination for the first time the stomach bleeding warning applying to you history of stomach problems, such as heartburn high blood pressure heart disease liver cirrhosis bleeding problems diuretic use ulcers kidney disease reached age 60 or older ask a doctor or pharmacist before use if you are taking any other drug containing an nsaid (prescription or nonprescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug when using this product do not take more than the recommended dosage stop and ask a doctor if product has been used for 3 days you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have blood or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings reye's syndrome: children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. stomach bleeding warning: this product contains an nsaid, which may cause stomach bleeding. the chance is higher if you: take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take more or for a longer time than directed do not use: if you are on a sodium restricted diet if you are allergic to salicylates (including aspirin) unless directed by a doctor if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor ask a doctor before use if you have frequent, burning urination for the first time the stomach bleeding warning applying to you history of stomach problems, such as heartburn high blood pressure heart disease liver cirrhosis bleeding problems diuretic use ulcers kidney disease reached age 60 or older ask a doctor or pharmacist before use if you are taking any other drug containing an nsaid (prescription or nonprescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug when using this product do not take more than the recommended dosage stop and ask a doctor if product has been used for 3 days you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have blood or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not take more than the recommended dosage
Dosage and Administration:
Directions: adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. drink plenty of fluids. children under 12 years: ask a doctor.
Stop Use:
Stop and ask a doctor if product has been used for 3 days you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have blood or black stools, have stomach pain that does not get better ringing in the ears or a loss of hearing occurs
Use in Pregnancy:
If pregnant or breast feeding, ask a health professional before use.
Package Label Principal Display Panel:
Azo urinary tract defense antibacterial protection* antibacterial urinary pain relief methenamine and sodium salicylate (nsaid) * helps inhibit the progression of infection until you see your healthcare professional. azo is not intended to replace medical care. azo udt 24 azo udt pouch azo udt 18