Urinary Pain Relief Tablets

Urinary Pain Relief Tablets
SPL v2
SPL
SPL Set ID 6bf45f75-5a61-4f24-8468-741c945e71e5
Route
ORAL
Published
Effective Date 2021-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (95 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Starch, Corn Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: S159 Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-05-01

Description

Drug Facts

Purpose

Urinary tract analgesic


Medication Information

Purpose

Urinary tract analgesic

Description

Drug Facts

Uses

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Section 42229-5

Drug Facts

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 50570-1

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Warnings

Do not exceed recommended dosage

Directions
  • Adults and children 12 years and over: 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 years: Do not use without consulting a doctor
Other Information
  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain contact lenses and other items if handled after touching tablets.
  • Store at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.
Inactive Ingredients

colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

Questions Or Comments?

call 1-800-632-6900

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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Active Ingredient (in Each Tablet)

Phenazopyridine Hydrochloride 95 mg

Ask A Doctor Before Use If You Have
  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine
Principal Display Panel 95 Mg Tablet Blister Pack Carton

*Compare to active ingredient of AZO® URINARY

PAIN RELIEF MAXIMUM STRENGTH *see back panel

NDC XXXXX-XXX-XX

Urinary

Pain Relief

Phenazopyridine

Hydrochloride 95 mg

FAST RELIEF

FOR URINARY

DISCONFORT

actual

size

30 TABLETS


Structured Label Content

Uses

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions

Section 42229-5 (42229-5)

Drug Facts

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 50570-1 (50570-1)

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Purpose

Urinary tract analgesic

Warnings

Do not exceed recommended dosage

Directions
  • Adults and children 12 years and over: 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 years: Do not use without consulting a doctor
Other Information (Other information)
  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain contact lenses and other items if handled after touching tablets.
  • Store at room temperature between 15°C -30°C (59°F -86°F) in a dry place and protect from light.
Inactive Ingredients (Inactive ingredients)

colloidal silicone dioxide, gum acacia extra pure, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

call 1-800-632-6900

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 (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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenazopyridine Hydrochloride 95 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine
Principal Display Panel 95 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 95 mg Tablet Blister Pack Carton)

*Compare to active ingredient of AZO® URINARY

PAIN RELIEF MAXIMUM STRENGTH *see back panel

NDC XXXXX-XXX-XX

Urinary

Pain Relief

Phenazopyridine

Hydrochloride 95 mg

FAST RELIEF

FOR URINARY

DISCONFORT

actual

size

30 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)