Phenazopyridine Hydrochloride is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Maximum Strength Urinary Pain Relief, Good Neighbor Pharmacy Urinary Pain Relief, Preferred Maximum Strength Urinary Pain Relief
- Taken
- Oral
- Label
- NUVICARE LLC, revised August 3, 2026 · full label on DailyMed
Purpose
Urinary tract analgesic
What it is used for
Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Active ingredient
Phenazopyridine Hydrochloride 99.5 mg
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride.
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.
Warnings
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.
Keep out of reach of children
. In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Phenazopyridine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Terminated
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
Reason: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots, distribution and details
- Lots / codes
- Lot # B2906961-042524, exp. date 02/26/2027
- Distribution
- Product was distributed to one medical facility.
- Quantity
- 8 bottles
- Recall started
- May 31, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0549-2024
-
Class II Completed
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Reason: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots, distribution and details
- Lots / codes
- Lot#: 1142404 Exp. Date 02/27/2027
- Distribution
- Nationwide within the United States
- Quantity
- 473 cases (5676 Bottles)
- Recall started
- May 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0545-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Phenazopyridine Hydrochloride
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 5fe4e4dc-f1c4-4617-b6a6-6ea16a63abfe.