Azo Tablet
FDA Label NDC 49973-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by I-health, Inc. for the product Azo (NDC 49973-301). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ General Precautions

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg

Otc - Purpose

Purpose

Urinary analgesic

Indications & Usage

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

Warnings

Warnings Please read insert for important precautions.

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

Caution: Do not use this product if 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

your symptoms last for more than 2 days
you suspect you are having an adverse reaction to the medication.

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 or 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.

General Precautions

Other Information

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 (59-86 F) in a dry place and protect from light
Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.

Inactive Ingredient

Inactive ingredientsmicrocrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.