Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 57067c80-d442-463a-babf-c5d3057cd9b4
Route
ORAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pulsatilla Pratensis Whole (4 [hp_X]) Euphorbia Resinifera Resin (6 [hp_X]) Luffa Operculata Fruit (8 [hp_X]) Mercuric Iodide (10 [hp_X]) Silver Cation (12 [hp_X]) Calcium Sulfide (17 [hp_X]) Influenza A Virus A/victoria/361/2011 Ivr-165 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated) (10 [hp_C]) Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated) (30 [hp_C]) Influenza B Virus B/washington/02/2019 Hemagglutinin Antigen (formaldehyde Inactivated) Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated) Sinusitisinum Aspergillus Niger Var. Niger Candida Albicans Gallic Acid Mucor Racemosus Escherichia Coli
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2021-11-22 Until 2027-08-05

Description

Pulsatilla (Pratensis) 4X, Euphorbium Officinarum 6X, Luffa Operculata 6X, Mercurius Iodatus Ruber 8X, Argentum Nitricum 10X, Hepar Sulphuris Calcareum 10X, Influenzinum (2021-2022) 12X, Sinusitisinum 17X, Aspergillus Niger 10C, 15C, 30C, 200C, Candida Albicans 10C, 15C, 30C, 200C, Gallicum Acidum 10C, 15C, 30C, 200C, Mucor Racemosus 10C, 15C, 30C, 200C, Mutabile Bacillus (Bach) 30C.


Medication Information

Description

Pulsatilla (Pratensis) 4X, Euphorbium Officinarum 6X, Luffa Operculata 6X, Mercurius Iodatus Ruber 8X, Argentum Nitricum 10X, Hepar Sulphuris Calcareum 10X, Influenzinum (2021-2022) 12X, Sinusitisinum 17X, Aspergillus Niger 10C, 15C, 30C, 200C, Candida Albicans 10C, 15C, 30C, 200C, Gallicum Acidum 10C, 15C, 30C, 200C, Mucor Racemosus 10C, 15C, 30C, 200C, Mutabile Bacillus (Bach) 30C.

Warnings:

Keep out of reach of children. In case of overdose, contact a physician or 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:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Pulsatilla (Pratensis) 4X, Euphorbium Officinarum 6X, Luffa Operculata 6X, Mercurius Iodatus Ruber 8X, Argentum Nitricum 10X, Hepar Sulphuris Calcareum 10X, Influenzinum (2021-2022) 12X, Sinusitisinum 17X, Aspergillus Niger 10C, 15C, 30C, 200C, Candida Albicans 10C, 15C, 30C, 200C, Gallicum Acidum 10C, 15C, 30C, 200C, Mucor Racemosus 10C, 15C, 30C, 200C, Mutabile Bacillus (Bach) 30C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

DESBIO

NDC 43742-2041-1

HOMEOPATHIC

ENT

SUPPORT

1 FL OZ (30 ml)

Homeopathic Indications:

For temporary relief of symptoms related to ear, nose and throat infections including sinus/nasal congestion, cough, and mucous congestion in the middle ear and sneezing.**

**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, contact a physician or Poison Control Center right away.


Structured Label Content

Warnings: (WARNINGS:)

Keep out of reach of children. In case of overdose, contact a physician or 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:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Pulsatilla (Pratensis) 4X, Euphorbium Officinarum 6X, Luffa Operculata 6X, Mercurius Iodatus Ruber 8X, Argentum Nitricum 10X, Hepar Sulphuris Calcareum 10X, Influenzinum (2021-2022) 12X, Sinusitisinum 17X, Aspergillus Niger 10C, 15C, 30C, 200C, Candida Albicans 10C, 15C, 30C, 200C, Gallicum Acidum 10C, 15C, 30C, 200C, Mucor Racemosus 10C, 15C, 30C, 200C, Mutabile Bacillus (Bach) 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-2041-1

HOMEOPATHIC

ENT

SUPPORT

1 FL OZ (30 ml)

Homeopathic Indications: (HOMEOPATHIC INDICATIONS:)

For temporary relief of symptoms related to ear, nose and throat infections including sinus/nasal congestion, cough, and mucous congestion in the middle ear and sneezing.**

**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, contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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