Methenamine, Sodium Salicylate, and Phenazopyridine Hydrochloride

FDA Drug Profile — All-In-One UTI Emergency Kit

Drug Details

Generic Name
Methenamine, Sodium Salicylate, and Phenazopyridine Hydrochloride
Brand Names
All-In-One UTI Emergency Kit
Application Number
Sponsor
Bonafide Health, LLC dba Uqora
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

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.

Warnings

Warnings 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 (UTI Infection Control Only) Stomach bleeding warning: This product contains a nonsteroidal 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 Do not use : 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 Ask a doctor before use if you have: 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 diect (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 (UTI Infection Control Only) Ask a doctor or pharmacist before use if you are: 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 When using this product: 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 Stop use and ask a doctor if : 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) 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 Breast Feeding UTI Infection Control If pregnant or breast feeding, 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 The Reach Of Children 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