Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 46816822-d850-44a7-a053-1c1bc12731c4
Route
ORAL
Published
Effective Date 2023-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clostridium Tetani (16 [hp_X]) Chlamydia Trachomatis (20 [hp_X]) Escherichia Coli (30 [hp_X]) Klebsiella Pneumoniae (15 [hp_C]) Mycobacterium Avium Subsp. Paratuberculosis (18 [hp_C]) Mycoplasma Pneumoniae Streptococcus Pneumoniae Salmonella Enterica Enterica Serovar Typhi Staphylococcus Aureus Streptococcus Viridans Group Rancid Beef Human Sputum, Bordetella Pertussis Infected Streptococcus Agalactiae Streptococcus Dysgalactiae Streptococcus Mutans Bacillus Cereus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-05-03 Until 2028-10-16

Description

Bacillus Tetani 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (e Coli) 16X, Klebsiella Pneumoniae 16X, Mycobacterium Paratuberculosis 16X, Mycoplasma Pneumoniae 16X, Pneumococcinum 16X, Salmonella Typhi Nosode 16X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X, Pyrogenium 20X, Pertussinum 30X, Streptococcus Agalactiae 15C, Streptococcus Dysgalactiae 15C, Streptococcus Mutans 15C, Bacillus Cereus 18C.

Purpose

Aids in temporary relief of headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Bacillus Tetani 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (e Coli) 16X, Klebsiella Pneumoniae 16X, Mycobacterium Paratuberculosis 16X, Mycoplasma Pneumoniae 16X, Pneumococcinum 16X, Salmonella Typhi Nosode 16X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X, Pyrogenium 20X, Pertussinum 30X, Streptococcus Agalactiae 15C, Streptococcus Dysgalactiae 15C, Streptococcus Mutans 15C, Bacillus Cereus 18C.

Purpose:

Aids in temporary relief of headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

†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. 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 headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

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

Active Ingredients:

Bacillus Tetani 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (e Coli) 16X, Klebsiella Pneumoniae 16X, Mycobacterium Paratuberculosis 16X, Mycoplasma Pneumoniae 16X, Pneumococcinum 16X, Salmonella Typhi Nosode 16X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X, Pyrogenium 20X, Pertussinum 30X, Streptococcus Agalactiae 15C, Streptococcus Dysgalactiae 15C, Streptococcus Mutans 15C, Bacillus Cereus 18C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0069-1

BACTI-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 headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

†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. 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 headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Bacillus Tetani 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (e Coli) 16X, Klebsiella Pneumoniae 16X, Mycobacterium Paratuberculosis 16X, Mycoplasma Pneumoniae 16X, Pneumococcinum 16X, Salmonella Typhi Nosode 16X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X, Pyrogenium 20X, Pertussinum 30X, Streptococcus Agalactiae 15C, Streptococcus Dysgalactiae 15C, Streptococcus Mutans 15C, Bacillus Cereus 18C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0069-1

BACTI-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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