Otc - Active Ingredient
Active Ingredients (in each tablet):
Candida albicans 30X
Kreosotum 30X
Natrium muriaticum 12X
Sulphur 12X
Azo Tablet
FDA Label NDC 49973-667
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 49973-667). 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 - ask doctor, otc - stop use, otc - pregnancy or breast feeding, 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
Otc - Purpose
Purpose
Relief from vaginal itching, burning and discharge
Relief from vaginal itching, burning, odor and discharge
Relief from vaginal itching, burning, odor and discharge
Relief from vaginal itching, burning, odor and discharge
Indications & Usage
Use:
See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.
- Relieves the symptoms of itching and burning associated with vaginal yeast infections.
- Relieves occasional vaginal odor and discharge.
Warnings
Warnings:
For oral use only. This product will not cure a yeast infection.
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Otc - Ask Doctor
Ask a doctor before use if you
- have vaginal itching and discomfort for the first time.
- have abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a serious condition.
- get vaginal yeast infections often (such as once a month or three in six months).
- may have been exposed to human immunodeficiency virus (HIV) that causes AIDS.
Otc - Stop Use
Stop use and contact your physician if
- your symptoms do not improve within 3 days or if symptoms last more than 7 days.
- you get a rash, hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: Adults: take one tablet orally three times a day as long as symptoms persist. Children: consult a physician prior to use.
- For occasional support take one tablet per day.
Other Safety Information
OtherInformation: Each one tablet dose contains 35 mg calcium. Store at room temperature. Do not expose to excessive heat, humidity or direct sunlight.
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
Inactive Ingredient
Inactive Ingredients: Dicalcium phosphate, fractionated cocunut and palm kernel oil, hypromellose, magnesium stearate, and microcrystalline cellulose.
General Precautions
This is a homeopathic medicine that supports the body's own defense system. Because this product contains natural ingredients, color may vary.
Otc - Questions
For questions, concerns, or to report an adverse event, call (800) 722-3476
Distributed by i-Health, Inc.
55 Sebethe Drive,
Cromwell, CT 06416
Made in the USA with US and imported materials.
Package Label.Principal Display Panel
AZO
Yeast Plus
Yeast Infection Symptom Relief:*
ITCHING
BURNING
Vaginal Symptom Relief:*
OCCASIONAL ODOR &
DISCHARGE
#1 MOST TRUSTED BRAND
___ Tablets
Homeopathic Medicine Lactose Free
* THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION
* Please review the disclaimer below.
