FDA Label for Azo
View Indications, Usage & Precautions
Azo Product Label
The following document was submitted to the FDA by the labeler of this product I-health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Questions
Distributed by i-Health, Inc.
55 Sebethe Drive, Cromwell, CT 06416
Made in India.
Most Trusted Brand based on Nielsen data through 3/23/2013.
For questions, concerns, or to report an adverse event, call (800) 722-3476
www.azoproducts.com
Package Label.Principal Display Panel
AZO Urinary Pain Relief
- Relieves pain, burning & urgency
- Targets the source of pain
#1 Most Trusted Brand
Tablets
95 mg Phenazopyridine Hydrochloride
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