Premier Value Antibacterial Plus Urinary Pain Relief Tablet
FDA Label NDC 68016-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Antibacterial Plus Urinary Pain Relief (NDC 68016-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients (in each tablet):, purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients (In Each Tablet):

Methenamine 162 mg

Sodium Salicylate 162.5 mg (NSAID Nonsteroidal Anti-Inflammatory Drug)

Purpose

Antibacterial

Analgesic (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 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 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 & 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 RELIEVER
  • Antibacterial Urinary Pain Relief

    Methenamine and Sodium Salicylate (NSAID)

Packaging

Carton (Carton)

Carton (Carton)

* Please review the disclaimer below.