NDC 36800-314 Topcare Antibacterial Plus Urinary Pain Relief

Methenamine, Sodium Salicylate

NDC Product Code 36800-314

NDC CODE: 36800-314

Proprietary Name: Topcare Antibacterial Plus Urinary Pain Relief 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: Methenamine, Sodium Salicylate 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.

NDC Code Structure

  • 36800 - Topco Associates Llc
    • 36800-314 - Topcare Antibacterial Plus Urinary Pain Relief

NDC 36800-314-24

Package Description: 1 BLISTER PACK in 1 CARTON > 24 TABLET in 1 BLISTER PACK

NDC Product Information

Topcare Antibacterial Plus Urinary Pain Relief with NDC 36800-314 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Antibacterial Plus Urinary Pain Relief is methenamine, sodium salicylate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Topcare Antibacterial Plus Urinary Pain Relief 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.

  • METHENAMINE 162 mg/1
  • SODIUM SALICYLATE 162.5 mg/1

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Topco Associates Llc
Labeler Code: 36800
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-22-2017 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Topcare Antibacterial Plus Urinary Pain Relief Product Label Images

Topcare Antibacterial Plus Urinary Pain Relief 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

Active Ingredients (In Each Tablet):

Methenamine 162 mgSodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)

Purpose

AntibacterialAnalgesic (pain reliever)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses Temporarily relieves: pain & burning • frequency and urgency of urination

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 directedDo 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 doctorAsk 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 olderAsk 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 drugWhen using this product • do not take more than the recommended dosageStop 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 occursIf pregnant or breast feeding, ask a health professional before use.

Dosage & 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

Inactive Ingredient

Inactive ingredients:benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Storage And Handling

Other Information: • each tablet contains 25 mg of sodium • store at 59-86°F (15-30°C) in a dry place • protect from light • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.

Other

  • HELPS CONTROL THE INFECTION*PLUS GENERAL PAIN RELIEVERAntibacterial Urinary Pain ReliefMethenamine and Sodium Salicylate (NSAID)

* Please review the disclaimer below.