Phenazopyridine Hydrochloride Tablet
FDA Label NDC 50696-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gpt Pharmaceuticals Private Limited for the product Phenazopyridine Hydrochloride (NDC 50696-003). 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 other, active ingredient (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Phenazopyridine Hydrochloride 99.5 mg

Warnings

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have

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

Do Not Use

if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

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 hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

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.

Keep Out Of Reach Of Children.

In case of an overdose, get medical help or contact a Poison Control Center call (1-800-222-1222) right away.

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

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 in a tightly closed container

Inactive Ingredients

colloidal silicone dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, povidone, pregelatinized starch

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