Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 6f8cfcad-4d23-44d3-9369-22b575b1e7e6
Route
ORAL
Published
Effective Date 2023-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Thuja Occidentalis Leafy Twig (6 [hp_X]) Oyster Shell Calcium Carbonate, Crude (9 [hp_X]) Silicon Dioxide (18 [hp_X]) Salmonella Enterica Enterica Serovar Typhi (30 [hp_X]) Anguilla Rostrata Blood Serum (18 [hp_C]) Clostridium Tetani Vaccinia Virus Measles Virus Mumps Virus Rubella Virus Yersinia Enterocolitica Salmonella Enterica Enterica Serovar Enteritidis
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-09-11 Until 2028-09-21

Description

Thuja Occidentalis 6X, 30X, Calcarea Carbonica 9X, 30X, Silicea 9X, 30X, Salmonella Typhi Nosode 18X, Serum Anguillae 18X, Bacillus Tetani (Clostridium Tetani) 30X, Malandrinum 30X, Morbillinum 30X, Parotidinum 30X, Rubella Nosode 30X, Yersinia Enterocolitica 30X, Salmonella Enteriditis 18C.

Purpose

Aids in temporary relief of symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Thuja Occidentalis 6X, 30X, Calcarea Carbonica 9X, 30X, Silicea 9X, 30X, Salmonella Typhi Nosode 18X, Serum Anguillae 18X, Bacillus Tetani (Clostridium Tetani) 30X, Malandrinum 30X, Morbillinum 30X, Parotidinum 30X, Rubella Nosode 30X, Yersinia Enterocolitica 30X, Salmonella Enteriditis 18C.

Purpose:

Aids in temporary relief of symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

†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 high 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 symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

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

Active Ingredients:

Thuja Occidentalis 6X, 30X, Calcarea Carbonica 9X, 30X, Silicea 9X, 30X, Salmonella Typhi Nosode 18X, Serum Anguillae 18X, Bacillus Tetani (Clostridium Tetani) 30X, Malandrinum 30X, Morbillinum 30X, Parotidinum 30X, Rubella Nosode 30X, Yersinia Enterocolitica 30X, Salmonella Enteriditis 18C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0071-1

VAX-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 symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

†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 high 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 symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Thuja Occidentalis 6X, 30X, Calcarea Carbonica 9X, 30X, Silicea 9X, 30X, Salmonella Typhi Nosode 18X, Serum Anguillae 18X, Bacillus Tetani (Clostridium Tetani) 30X, Malandrinum 30X, Morbillinum 30X, Parotidinum 30X, Rubella Nosode 30X, Yersinia Enterocolitica 30X, Salmonella Enteriditis 18C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0071-1

VAX-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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