Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID c6055c02-a365-4adf-9d3a-47d717c4c93d
Route
ORAL
Published
Effective Date 2023-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe (6 [hp_X]) Goldenseal (12 [hp_X]) Garlic (16 [hp_X]) Bacillus Anthracis Immunoserum Rabbit (16 [hp_Q]) Clostridium Tetani (20 [hp_X]) Brucella Abortus (30 [hp_X]) Escherichia Coli (18 [hp_C]) Klebsiella Pneumoniae Mycoplasma Pneumoniae Streptococcus Pneumoniae Proteus Vulgaris Pseudomonas Aeruginosa Staphylococcus Aureus Streptococcus Viridans Group Delphinium Staphisagria Seed Eucalyptol Rancid Beef Canis Lupus Familiaris Milk Cow Milk Human Sputum, Bordetella Pertussis Infected Bacillus Cereus Clostridium Perfringens Coxiella Burnetii Rickettsia Prowazekii Serratia Marcescens
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-09-15

Description

Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella Pneumoniae 16X, 30X, Mycoplasma Pneumoniae 16X, 30X, Pneumococcinum 16X, 30X, Proteus 16X, 30X, Pseudomonas Aeruginosa 16X, 30X, Staphylococcus Aureus 16X, 30X, Streptococcus Viridans 16X, 30X, Staphysagria 16X, 30X, 100X, Eucalyptol 20X, Pyrogenium 20X, 30X, 100X, Lac Caninum 30X, Lac Vaccinum 30X, Pertussinum 30X, Bacillus Cereus 18C, 30C, Clostridium Perfringens 18C, 30C, Coxiella Burnetii 18C, 30C, Rickettsia Nosode 18C, 30C, Serratia Marcescens 18C, 30C.

Purpose

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

Description

Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella Pneumoniae 16X, 30X, Mycoplasma Pneumoniae 16X, 30X, Pneumococcinum 16X, 30X, Proteus 16X, 30X, Pseudomonas Aeruginosa 16X, 30X, Staphylococcus Aureus 16X, 30X, Streptococcus Viridans 16X, 30X, Staphysagria 16X, 30X, 100X, Eucalyptol 20X, Pyrogenium 20X, 30X, 100X, Lac Caninum 30X, Lac Vaccinum 30X, Pertussinum 30X, Bacillus Cereus 18C, 30C, Clostridium Perfringens 18C, 30C, Coxiella Burnetii 18C, 30C, Rickettsia Nosode 18C, 30C, Serratia Marcescens 18C, 30C.

Purpose:

Aids in temporary relief of headaches, 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 headaches, 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:

Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella Pneumoniae 16X, 30X, Mycoplasma Pneumoniae 16X, 30X, Pneumococcinum 16X, 30X, Proteus 16X, 30X, Pseudomonas Aeruginosa 16X, 30X, Staphylococcus Aureus 16X, 30X, Streptococcus Viridans 16X, 30X, Staphysagria 16X, 30X, 100X, Eucalyptol 20X, Pyrogenium 20X, 30X, 100X, Lac Caninum 30X, Lac Vaccinum 30X, Pertussinum 30X, Bacillus Cereus 18C, 30C, Clostridium Perfringens 18C, 30C, Coxiella Burnetii 18C, 30C, Rickettsia Nosode 18C, 30C, Serratia Marcescens 18C, 30C.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0047-1

BACTEX

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 headaches, 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 headaches, 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:)

Aloe 6X, Hydrastis Canadensis 6X, Allium Sativum 12X, Anthracinum 16X, 30X, Bacillus Tetani 16X, 30X, Brucella Abortus 16X, 30X, Colibacillinum Cum Natrum Muriaticum 16X, 30X, Klebsiella Pneumoniae 16X, 30X, Mycoplasma Pneumoniae 16X, 30X, Pneumococcinum 16X, 30X, Proteus 16X, 30X, Pseudomonas Aeruginosa 16X, 30X, Staphylococcus Aureus 16X, 30X, Streptococcus Viridans 16X, 30X, Staphysagria 16X, 30X, 100X, Eucalyptol 20X, Pyrogenium 20X, 30X, 100X, Lac Caninum 30X, Lac Vaccinum 30X, Pertussinum 30X, Bacillus Cereus 18C, 30C, Clostridium Perfringens 18C, 30C, Coxiella Burnetii 18C, 30C, Rickettsia Nosode 18C, 30C, Serratia Marcescens 18C, 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0047-1

BACTEX

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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