DRUG FACTS:

Drug Labeling and Warnings

Drug Details [pdf]

FUNGAL PLUS- candida albicans liquid 
Dr. Elena M. Morreale, Chiropractic Life Center

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Candida Albicans 6X, 12X, 30X, 60X 100X, 200X, 500X

INDICATIONS:

To be used according to standard homeopathic indications.

WARNINGS:

​If pregnant or breast-feeding,​ ask a health professional before use.

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

To be used according to standard homeopathic indications.

INACTIVE INGREDIENTS:

Demineralized Water, 20% Ethanol

QUESTIONS:

Dist. by Dr. Elena M. Morreale

10031 N. Dale Mabry Hwy. Ste. A

Tampa, FL 33618

www.drelenamorreale.com

PACKAGE LABEL DISPLAY:

Dr. Elena M. Morreale
Chiropractic Physician
FUNGAL PLUS
Homeopathic Remedy
1 fl. oz. (30 ml)

FUNGAL PLUS 
candida albicans liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50813-0004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50813-0004-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/12/2013	08/20/2019

Labeler - Dr. Elena M. Morreale, Chiropractic Life Center (826038759)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50813-0004) , api manufacture(50813-0004) , label(50813-0004) , pack(50813-0004)

Revised: 2/2016

Document Id: 61625dde-bb4a-4458-84ad-2d1dc1c768fe

Set id: ce32a2b5-3716-4a4d-a066-d83f165b9a72

Version: 3

Effective Time: 20160217

 

Dr. Ele