phenazopyridine hydrochloride tablets

phenazopyridine hydrochloride tablets
SPL v2
SPL
SPL Set ID a27b19a3-53e4-4887-bdf2-f1083ebff79d
Route
oral
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenazopyridine (99.5 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: p99 Shape: capsule Color: red Size: 9 mm Score: 1
Marketing Status
unapproved drug other active Since 2024-03-12

Description

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 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
Active Ingredient

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

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 99.5 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 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- 029-09

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

  • Relieves Pain, Burning and Urgency
  • Targets the source of Pain

12 Tablets

Blister Label


Structured Label Content

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
Active Ingredient (55106-9)

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

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.
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 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- 029-09

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

  • Relieves Pain, Burning and Urgency
  • Targets the source of Pain

12 Tablets

Blister Label


Advanced Ingredient Data


Raw Label Data

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