SPL v4
SPL
SPL Set ID d10f1cab-7489-481a-9fe2-002d419acd37
Route
ORAL
Published
Effective Date 2017-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methenamine (162 mg) Salicylic Acid (162.5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-02-22

Description

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

Purpose

Antibacterial Analgesic (pain reliever)


Medication Information

Indications and Usage

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

Purpose

Antibacterial

Analgesic (pain reliever)

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

Description

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

Section 42229-5
  • HELPS CONTROL THE INFECTION*
  • PLUS GENERAL PAIN RELIEVER

Antibacterial Urinary Pain Relief

Methenamine and Sodium Salicylate (NSAID)

Section 44425-7

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.

Section 50565-1

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

Section 51727-6

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

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.

Packaging

Drug Facts

Active Ingredients (in Each Tablet):

Methenamine 162 mg

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)
  • HELPS CONTROL THE INFECTION*
  • PLUS GENERAL PAIN RELIEVER

Antibacterial Urinary Pain Relief

Methenamine and Sodium Salicylate (NSAID)

Section 44425-7 (44425-7)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Purpose

Antibacterial

Analgesic (pain reliever)

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.

Packaging

Drug Facts

Active Ingredients (in Each Tablet): (Active Ingredients (in each tablet):)

Methenamine 162 mg

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)