drug facts:

drug facts:
SPL v3
SPL
SPL Set ID 1f4a9fda-c53e-4c0c-b624-aa48436c0aea
Route
oral
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
horseradish (3 [hp_X]) echinacea angustifolia (6 [hp_X]) marsdenia condurango bark (8 [hp_X]) ginkgo (12 [hp_X]) pinus sylvestris leafy twig (15 [hp_X]) propolis wax sus scrofa spleen handroanthus impetiginosus whole bos taurus thymus bee pollen calcium sulfide sus scrofa bone marrow phosphoric acid lachesis muta venom
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2020-12-28

Description

Cochlearia Armoracia 3X, Echinacea (Angustifolia) 3X, Condurango 6X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Propolis 6X, Spleen (suis) 6X, Tabebuia Impetiginosa 6X, Thymus (Bovine) 6X, Bee Pollen 8X, Hepar Sulphuris Calcareum 8X, Medulla Ossis Suis 8X, Phosphoricum Acidum 12X, Lachesis Mutus 15X.


Medication Information

Description

Cochlearia Armoracia 3X, Echinacea (Angustifolia) 3X, Condurango 6X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Propolis 6X, Spleen (suis) 6X, Tabebuia Impetiginosa 6X, Thymus (Bovine) 6X, Bee Pollen 8X, Hepar Sulphuris Calcareum 8X, Medulla Ossis Suis 8X, Phosphoricum Acidum 12X, Lachesis Mutus 15X.

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 cool, dry place.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 sore throat, fever, persistent cough, and fatigue associated with flu.

Active Ingredients:

Cochlearia Armoracia 3X, Echinacea (Angustifolia) 3X, Condurango 6X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Propolis 6X, Spleen (suis) 6X, Tabebuia Impetiginosa 6X, Thymus (Bovine) 6X, Bee Pollen 8X, Hepar Sulphuris Calcareum 8X, Medulla Ossis Suis 8X, Phosphoricum Acidum 12X, Lachesis Mutus 15X.

Inactive Ingredients:

Demineralized water, 25% Ethanol.

Package Label Display:

BioActive Homeopathic

THYMOPLEX

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 cool, dry place.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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 sore throat, fever, persistent cough, and fatigue associated with flu.

Active Ingredients: (ACTIVE INGREDIENTS:)

Cochlearia Armoracia 3X, Echinacea (Angustifolia) 3X, Condurango 6X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Propolis 6X, Spleen (suis) 6X, Tabebuia Impetiginosa 6X, Thymus (Bovine) 6X, Bee Pollen 8X, Hepar Sulphuris Calcareum 8X, Medulla Ossis Suis 8X, Phosphoricum Acidum 12X, Lachesis Mutus 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BioActive Homeopathic

THYMOPLEX

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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