FDA Label for Foster And Thrive Neighbor Pharmacy Urinary Pain Relief
View Indications, Usage & Precautions
Foster And Thrive Neighbor Pharmacy Urinary Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Phenazopyridine Hydrochloride 95 mg
Purpose
Urinary Analgesic
Uses
fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.
Warning
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician
Ask Doctor Before Use If You Have
■ kidney disease
■ allergies to foods, preservatives or dyes
■ had a hypersensitive reaction to Phenazopyridine
When Using This Product
■ When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset
■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
Stop Use And Ask A Doctor If
■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication
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
ask a health professional before use.
Keep Out Of The Reach Of Children
in case of an overdose,get medical help or contact a Poison Control Center right away 1-800-222-1222.
Directions
■ 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
■ Children under 12 years: consult a doctor
■ Do not use for more than 2 days (12 tablets) without consulting a doctor
Other Information
■ this product may stain contact lenses
■ this product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
■ Store at room temperature 15-30C (59-86°F) in a dry place and protect from light
Inactive Ingredients
lactose, corn starch, croscarmellose sodium, microcrystalline
cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate,
pregelatinized starch, silicon dioxide, talc, and triacetin.
Package Label.Principal Display Panel
* Please review the disclaimer below.