Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID cf84f205-7195-400c-a56c-506a957dec01
Route
ORAL
Published
Effective Date 2021-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Lomatium Dissectum Root (5 [hp_X]) Myrrh (6 [hp_X]) Nasturtium Officinale (12 [hp_X]) Handroanthus Impetiginosus Bark (30 [hp_X]) Goldenseal (10 [hp_C]) Propolis Wax Bryonia Alba Root Eupatorium Perfoliatum Flowering Top Ferrosoferric Phosphate Gelsemium Sempervirens Root Ipecac Mercuric Cation Rancid Beef Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated) Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (h3n2) Hemagglutinin Antigen (formaldehyde Inactivated) Influenza B Virus B/phuket/3073/2013 Bvr-1b Hemagglutinin Antigen (formaldehyde Inactivated) Influenza B Virus B/washington/02/2019 Hemagglutinin Antigen (formaldehyde Inactivated)
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2021-05-20 Until 2026-06-23

Description

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Bryonia (Alba) 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Ipecacuanha 12X, Mercurius Corrosivus 12X, Pyrogenium 30X, 60X, 200X, Influenzinum (2020-2021) 10C, 30C, 200C.


Medication Information

Description

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Bryonia (Alba) 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Ipecacuanha 12X, Mercurius Corrosivus 12X, Pyrogenium 30X, 60X, 200X, Influenzinum (2020-2021) 10C, 30C, 200C.

Warnings:

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

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

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

Store in a cool, dry place.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough; muscular soreness and fatigue with headache.

Active Ingredients:

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Bryonia (Alba) 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Ipecacuanha 12X, Mercurius Corrosivus 12X, Pyrogenium 30X, 60X, 200X, Influenzinum (2020-2021) 10C, 30C, 200C.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

RESPIFORCE I

HOMEOPATHIC

1 FL OZ (30 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.


Structured Label Content

Warnings: (WARNINGS:)

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

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

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

Store in a cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough; muscular soreness and fatigue with headache.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Myrrha 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Propolis 6X, Bryonia (Alba) 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Ipecacuanha 12X, Mercurius Corrosivus 12X, Pyrogenium 30X, 60X, 200X, Influenzinum (2020-2021) 10C, 30C, 200C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

RESPIFORCE I

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (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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