Active ingredientMETHENAMINE, SODIUM SALICYLATE, PHENAZOPYRIDINE HYDROCHLORIDE
Label structure22 sections
Indications and uses
UTI Infection Control Temporarily relieves: pain and burning frequency and urgency of urination UTI Pain Relief Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.
Dosage and administration
UTI Infection Control Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Do not use for more than a 3 day period unless directed by a doctor. Children under 12 years: ask a doctor. UTI Pain Relief Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed Do not use for more than ...
Active Ingredient (in each tablet) - (UTI Pain Relief only)
OTC - ACTIVE INGREDIENT SECTION
Phenazopyridine Hydrochloride 99.5mg
Purpose - (UTI Pain Relief only)
OTC - PURPOSE SECTION
Urinary Tract Analgesic
Uses
INDICATIONS & USAGE SECTION
UTI Infection Control
Temporarily relieves:
pain and burning
frequency and urgency of urination
UTI Pain Relief
Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.
Warnings
WARNINGS SECTION
Reye's Syndrome
(UTI Infection Control Only)
Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using 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 a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:
are 60 or older
have stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Do Not Exceed
(UTI Pain Relief Only)
Do not exceed recommended dosage
Do Not Use:
OTC - DO NOT USE SECTION
If you are allergic to salicylates (including aspirin) (
UTI Infection Control only)
If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your doctor (
UTI Pain Relief only)
Ask a doctor before use if you have:
OTC - ASK DOCTOR SECTION
frequent, burning urination for the first time
(UTI Infection Control only)
the stomach bleeding warning applying to you
(UTI Infection Control only)
history of stomach problems, such as heartburn
(UTI Infection Control only)
high blood pressure
(UTI Infection Control only)
heart disease
(UTI Infection Control only)
liver cirrhosis
(UTI Infection Control only)
bleeding problems
(UTI Infection Control only)
diuretic use
(UTI Infection Control only)
ulcers
(UTI Infection Control only)
kidney disease
a sodium restricted diet
(UTI Infection Control only)
reached age 60 or older
(UTI Infection Control only)
allergies to foods, preservatives or dyes
(UTI Pain Relief only)
had a hypersensitive reaction to phenazopyridine
(UTI Pain Relief only)
Ask a doctor or pharmacist before use if you are:
OTC - ASK DOCTOR/PHARMACIST SECTION
taking any other drug containing an NSAID (prescription or non-prescription)
taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug
When using this product:
OTC - WHEN USING SECTION
do not take more than the recommended dosage
(UTI Infection Control only)
stomach upset may occur, taking this product with or after meals may reduce stomach upset
(UTI Pain Relief only)
your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
(UTI Pain Relief only)
Stop use and ask a doctor if:
OTC - STOP USE SECTION
product has been used for 3 days
(UTI Infection Control only)
ringing in the ears
(UTI Infection Control only)
you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stool ■ have stomach pain or upset that gets worse or lasts
(UTI Infection Control only)
your symptoms last for more than 2 days
(UTI Pain Relief only)
you suspect you are having an adverse reaction to the medication
(UTI Pain Relief only)
Long Term Administration (UTI Pain Relief only)
USER SAFETY WARNINGS SECTION
Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
If pregnant or breastfeeding
OTC - PREGNANCY OR BREAST FEEDING SECTION
UTI Infection Control
If pregnant or breastfeeding,ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
UTI Pain Relief
If pregnant or breast feeding,ask a health professional before use.
Keep out of reach of children
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222
Directions
DOSAGE & ADMINISTRATION SECTION
UTI Infection Control
Adults and children 12 years and over:
take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids.
Do not use for more than a 3 day period unless directed by a doctor.
Children under 12 years:ask a doctor.
UTI Pain Relief
Adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed
Do not use for more than 2 days (12 tablets) without consulting a doctor.
Children under 12 years: ask a doctor.
Other information 1
OTHER SAFETY INFORMATION
UTI Infection Control
each tablet contains:sodium 24.4 mg
store at 59-86°F (15-30°C) in a dry place
protect from sunlight
Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged
UTI Pain Relief
this product may stain contact lenses
this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light
Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.