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NDC 49973-0667-20 AZO 30; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

AZO 30; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

AZO is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by i-Health, Inc.. The primary component is CANDIDA ALBICANS; SODIUM CHLORIDE; SULFUR; WOOD CREOSOTE.

Product Information

NDC	49973-0667
Product ID	49973-667_d10299a1-ae3b-d408-e053-2a95a90acda3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	AZO
Proprietary Name Suffix	Yeast Plus
Non-Proprietary Name	Candida Albicans, Wood Creosote, Sodium Chloride, and Sulfur
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30; 12; 12; 30
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	CANDIDA ALBICANS; SODIUM CHLORIDE; SULFUR; WOOD CREOSOTE
Labeler Name	i-Health, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49973-0667-20 (49973066720)

Pricing Information	N/A
NDC Package Code	49973-667-20
Billing NDC	49973066720
Package	20 BLISTER PACK in 1 BOX (49973-667-20) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2018-04-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 22845cac-8011-4ea8-b35e-b72973eddb44 Details

SPL UNCLASSIFIED SECTION

Active Ingredients (in each tablet):

Candida albicans 30X

Kreosotum 30X

Natrium muriaticum 12X

Sulphur 12X

SPL UNCLASSIFIED SECTION

Purpose

Relief from vaginal itching, burning and discharge

Relief from vaginal itching, burning, odor and discharge

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

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.

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.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Inactive Ingredients: Dicalcium phosphate, fractionated cocunut and palm kernel oil, hypromellose, magnesium stearate, and microcrystalline cellulose.

SPL UNCLASSIFIED SECTION

This is a homeopathic medicine that supports the body's own defense system. Because this product contains natural ingredients, color may vary.

SPL UNCLASSIFIED SECTION

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

Distributed by i-Health, Inc.

55 Sebethe Drive,

Cromwell, CT 06416

Made in the USA with US and imported materials.

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

INGREDIENTS AND APPEARANCE

AZO YEAST PLUS

candida albicans, wood creosote, sodium chloride, and sulfur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49973-667
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_X]
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	30 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	A
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49973-667-60	60 in 1 BOX	04/01/2014
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:49973-667-20	20 in 1 BOX	04/25/2018
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2014

Labeler - i-Health, Inc. (061427694)

Revised: 11/2021

Document Id: d10299a1-ae3b-d408-e053-2a95a90acda3

Set id: 22845cac-8011-4ea8-b35e-b72973eddb44

Version: 5

Effective Time: 20211117

Search by Drug Name or NDC

NDC 49973-0667-20 AZO 30; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

AZO 30; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 49973-0667-20 (49973066720)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 22845cac-8011-4ea8-b35e-b72973eddb44 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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