Phenazopyridine Hydrochloride Tablets

Phenazopyridine Hydrochloride Tablets
SPL v2
SPL
SPL Set ID 5539356d-10ed-44df-8d17-1af6bd6d982f
Route
ORAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (95 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Corn Hypromellose, Unspecified Povidone, Unspecified Croscarmellose Sodium Polyethylene Glycol, Unspecified Carnauba Wax Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: p Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-03-11

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

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