Phenazopyridine Hydrochloride Tablets
5539356d-10ed-44df-8d17-1af6bd6d982f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg
Medication Information
Warnings and Precautions
Warnings
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
Indications and Usage
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Dosage and Administration
Directions
- Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
- Children under 12: Do not use without consulting a doctor.
Description
Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg
Section 42229-5
Questions or comments? Call 1-844-200-6566
Distributed by:
Drug Ocean LLC
1 Bridge Plaza, North Central Road,
6th Floor, Suite 675,
Fort Lee, NJ 07024
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750
ORG 03/2024
Section 50565-1
Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask doctor if
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication.
Section 50567-7
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.
Section 50570-1
Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6
Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.
Section 53414-9
If pregnant or breastfeeding,ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.
Section 55105-1
Purpose
Urinary tract analgesic
Section 55106-9
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Section 60561-8
Other Information
- This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59 o-86 oF) in a dry place and protect from light.
Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
Packaging
Drug Ocean NDC 70985- 028-14
Phenazopyridine Hydrochloride Tablets, 95 mg
Urinary Tract Pain Relief
- Relieves Pain, Burning and Urgency
- Targets the source of Pain
30 Tablets
Blister Label
Structured Label Content
Indications and Usage (34067-9)
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Dosage and Administration (34068-7)
Directions
- Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.
- Children under 12: Do not use without consulting a doctor.
Warnings and Precautions (34071-1)
Warnings
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
Section 42229-5 (42229-5)
Questions or comments? Call 1-844-200-6566
Distributed by:
Drug Ocean LLC
1 Bridge Plaza, North Central Road,
6th Floor, Suite 675,
Fort Lee, NJ 07024
Made in India
Mfg License Code:
RA/Drug/RAJ.-1750
ORG 03/2024
Section 50565-1 (50565-1)
Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask doctor if
- your symptoms last for more than 2 days
- you suspect you are having an adverse reaction to the medication.
Section 50567-7 (50567-7)
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.
Section 50570-1 (50570-1)
Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Section 51727-6 (51727-6)
Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.
Section 53414-9 (53414-9)
If pregnant or breastfeeding,ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use.
Section 55105-1 (55105-1)
Purpose
Urinary tract analgesic
Section 55106-9 (55106-9)
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
Section 60561-8 (60561-8)
Other Information
- This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59 o-86 oF) in a dry place and protect from light.
Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
Packaging
Drug Ocean NDC 70985- 028-14
Phenazopyridine Hydrochloride Tablets, 95 mg
Urinary Tract Pain Relief
- Relieves Pain, Burning and Urgency
- Targets the source of Pain
30 Tablets
Blister Label
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:54.041244 · Updated: 2026-03-14T23:02:42.365017