drug facts:

drug facts:
SPL v2
SPL
SPL Set ID 9eac6756-3367-456e-9364-1bea7a5807f4
Route
oral
Published
Effective Date 2023-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaldehyde (6 [hp_X]) coumarin (10 [hp_X]) histamine (12 [hp_X]) quercetin (6 [hp_C]) saccharomyces cerevisiae (15 [hp_C]) candida albicans (30 [hp_C]) candida parapsilosis lactic acid, l- sepia officinalis juice corticotropin human alcaligenes faecalis
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2021-06-21

Description

Acetaldehyde 6X, 8X, 10X, 30X, 200X, Coumarinum 6X, 8X, 10X, 30X, 200X, Histaminum Hydrochloricum 6X, 8X, 10X, 30X, 200X, Quercetin 6X, 8X, 10X, 30X, 200X, Torula Cerevisiae 10X, 30X, 200X, Candida Albicans 12X, 30X, 200X, Candida Parapsilosis 12X, 30X, 200X, Adrenocorticotrophin 6C, 30C, 200C, Sarcolacticum Acidum 6C, 30C, 200C, Sepia 6C, 30C, 200C, Adrenocorticotrophin 15C, 30C, 200C,  Faecalis (Alkaligenes) 30C, 200C.


Medication Information

Description

Acetaldehyde 6X, 8X, 10X, 30X, 200X, Coumarinum 6X, 8X, 10X, 30X, 200X, Histaminum Hydrochloricum 6X, 8X, 10X, 30X, 200X, Quercetin 6X, 8X, 10X, 30X, 200X, Torula Cerevisiae 10X, 30X, 200X, Candida Albicans 12X, 30X, 200X, Candida Parapsilosis 12X, 30X, 200X, Adrenocorticotrophin 6C, 30C, 200C, Sarcolacticum Acidum 6C, 30C, 200C, Sepia 6C, 30C, 200C, Adrenocorticotrophin 15C, 30C, 200C,  Faecalis (Alkaligenes) 30C, 200C.

Warnings:

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

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

Tamper seal: Sealed for your protection.

Do not use if seal is broken or missing.

Questions:

Distributed by Dr. Donna Restivo DC, Wellness Consultant

822 South Lake Blvd, Mahopac, New York 10541

www.mahopacmassage.com (845) 628-6286

Directions:

10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Acetaldehyde 6X, 8X, 10X, 30X, 200X, Coumarinum 6X, 8X, 10X, 30X, 200X, Histaminum Hydrochloricum 6X, 8X, 10X, 30X, 200X, Quercetin 6X, 8X, 10X, 30X, 200X, Torula Cerevisiae 10X, 30X, 200X, Candida Albicans 12X, 30X, 200X, Candida Parapsilosis 12X, 30X, 200X, Adrenocorticotrophin 6C, 30C, 200C, Sarcolacticum Acidum 6C, 30C, 200C, Sepia 6C, 30C, 200C, Adrenocorticotrophin 15C, 30C, 200C,  Faecalis (Alkaligenes) 30C, 200C.

Inactive Ingredients:

demineralized water, 25% ethanol

Package Label Display:

DR. DONNA RESTIVO DC

WELLNESS CONSULTANT

NDC 62185-0064-1

HOMEOPATHIC

Bread Cravings

1 FL OZ (30 ml)

Homeopathic Indications:

Temporary relief of symptoms related to yeast syndrome including fatigue, malaise, weakness, headaches, GI disturbance, and anxiety.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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.


Structured Label Content

Warnings: (WARNINGS:)

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

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

Tamper seal: Sealed for your protection.

Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Distributed by Dr. Donna Restivo DC, Wellness Consultant

822 South Lake Blvd, Mahopac, New York 10541

www.mahopacmassage.com (845) 628-6286

Directions: (DIRECTIONS:)

10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Acetaldehyde 6X, 8X, 10X, 30X, 200X, Coumarinum 6X, 8X, 10X, 30X, 200X, Histaminum Hydrochloricum 6X, 8X, 10X, 30X, 200X, Quercetin 6X, 8X, 10X, 30X, 200X, Torula Cerevisiae 10X, 30X, 200X, Candida Albicans 12X, 30X, 200X, Candida Parapsilosis 12X, 30X, 200X, Adrenocorticotrophin 6C, 30C, 200C, Sarcolacticum Acidum 6C, 30C, 200C, Sepia 6C, 30C, 200C, Adrenocorticotrophin 15C, 30C, 200C,  Faecalis (Alkaligenes) 30C, 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DR. DONNA RESTIVO DC

WELLNESS CONSULTANT

NDC 62185-0064-1

HOMEOPATHIC

Bread Cravings

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

Temporary relief of symptoms related to yeast syndrome including fatigue, malaise, weakness, headaches, GI disturbance, and anxiety.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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