Phenazopyridine Hydrochloride
FDA Label NDC 70985-028

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drug Ocean Llc for the product Phenazopyridine Hydrochloride (NDC 70985-028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Otc - Purpose

Purpose

Urinary tract analgesic

Indications & Usage

UseRelief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings

Warnings

Ask a doctor before use if you have

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

Otc - Do Not Use

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

Otc - When Using

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.

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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. 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.

Dosage & 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.

Inactive Ingredient

Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

Other

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

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

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