Topcare Antibacterial Plus Urinary Pain Relief
Methenamine, Sodium Salicylate
Topco Associates Llc
Human Otc Drug
NDC 36800-314Topcare Antibacterial Plus Urinary Pain Relief also known as Methenamine, Sodium Salicylate is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Topcare Antibacterial Plus Urinary Pain Relief is 36800-314. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Topcare Antibacterial Plus Urinary Pain Relief drug includes Methenamine - 162 mg/1 Sodium Salicylate - 162.5 mg/1 . The currest status of Topcare Antibacterial Plus Urinary Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 36800-314 |
| 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: | Topcare Antibacterial Plus Urinary 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: | Methenamine, Sodium Salicylate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Topco Associates Llc |
| 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: | 22 Feb, 2017 |
| 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: | Topco Associates LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 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. |
| UPC: | 0036800444744
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 36800-314-24 | 1 BLISTER PACK in 1 CARTON (36800-314-24) / 24 TABLET in 1 BLISTER PACK | 22 Feb, 2017 | 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:
Topcare antibacterial plus urinary pain relief methenamine, sodium salicylate methenamine methenamine sodium salicylate salicylic acid benzoic acid croscarmellose sodium fd&c red no. 40 fd&c yellow no. 6 hypromelloses magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a cellulose, microcrystalline silicon dioxide stearic acid sodium bicarbonate sodium lauryl sulfate talc titanium dioxide triacetin triethyl citrate ph061
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 behaviour 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
Read more... 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 bloody 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.
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
Package Label Principal Display Panel:
Packaging carton