Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 4dbbd970-f3ad-4d96-9b54-7aa2c8323be2
Route
ORAL
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alternaria Alternata (16 [hp_X]) Aspergillus Niger Var. Niger (16 [hp_C]) Candida Albicans (32 [hp_C]) Candida Parapsilosis Mucor Racemosus Issatchenkia Orientalis Whole Rhizopus Stolonifer Candida Tropicalis
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-04-27 Until 2028-05-19

Description

Alternaria Tenuis Nees 16X, Aspergillus Niger 16X, Candida Albicans 16X, Candida Parapsilosis 16X, Mucor Racemosus 16X, Candida Krusei 16C, Rhizopus Nigricans 16C, Candida Tropicalis 32C.

Purpose

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Alternaria Tenuis Nees 16X, Aspergillus Niger 16X, Candida Albicans 16X, Candida Parapsilosis 16X, Mucor Racemosus 16X, Candida Krusei 16C, Rhizopus Nigricans 16C, Candida Tropicalis 32C.

Purpose:

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Professional Use Only

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

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

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

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

For highly sensitive individuals: best tolerated administration is through imbrication (RUBBING IN) on skin at pulse points or abdomen.

Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications:

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

Alternaria Tenuis Nees 16X, Aspergillus Niger 16X, Candida Albicans 16X, Candida Parapsilosis 16X, Mucor Racemosus 16X, Candida Krusei 16C, Rhizopus Nigricans 16C, Candida Tropicalis 32C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0068-1

MYCO-SODE

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Professional Use Only

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

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

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

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

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

For highly sensitive individuals: best tolerated administration is through imbrication (RUBBING IN) on skin at pulse points or abdomen.

Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Aids in temporary relief of rhinitis, itchy eyes, headache, runny nose, fatigue, red or itchy skin†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

Alternaria Tenuis Nees 16X, Aspergillus Niger 16X, Candida Albicans 16X, Candida Parapsilosis 16X, Mucor Racemosus 16X, Candida Krusei 16C, Rhizopus Nigricans 16C, Candida Tropicalis 32C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0068-1

MYCO-SODE

2 FL. OZ (60 ml)

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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