N01

N01
SPL v2
SPL
SPL Set ID bfc8e049-2f62-31c4-e053-2a95a90a6e16
Route
SUBLINGUAL
Published
Effective Date 2021-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (4 [hp_C]) Silver Cation (15 [hp_X]) Avena Sativa Flowering Top (1 [hp_X]) Berberis Vulgaris Root Bark (12 [hp_X]) Arnica Montana (2 [hp_X]) Sarsaparilla (30 [hp_X]) Gold (20 [hp_X]) Chelidonium Majus (3 [hp_X]) Nickel Silicon Dioxide Thuja Occidentalis Leafy Twig Solidago Virgaurea Flowering Top Valeric Acid Calcium Sulfide Fluoride Ion Quinine Hypericum Perforatum Passiflora Incarnata Top
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1997-07-15

Description

Active Ingredients Adrenalinum 4C Argentum Nitricum 6X 9X 12X 15X Arnica Montana 3X 12X Aurum Metallicum 12X 15X 20X 30X Avena Sativa 1X Berberis Vulgaris 1X Chelidonium Majus 1X Chininum Arsenicosum 4X 6X 8X 12X Hepar Sulphuris Calcareum 8X 10X 12X Hypericum Perforatum 3X Natrum Fluoratum 6X 8X 10X 12X Niccolum Metallicum 12X 15X Passiflora Incarnata 1X Sarsaparilla 2X Silicea 10X 12X 15X 20X Solidago Virgaurea 1X Thuja Occidentalis 6X 9X 12X Zincum Valerianicum 6X 9X 12X


Medication Information

Description

Active Ingredients Adrenalinum 4C Argentum Nitricum 6X 9X 12X 15X Arnica Montana 3X 12X Aurum Metallicum 12X 15X 20X 30X Avena Sativa 1X Berberis Vulgaris 1X Chelidonium Majus 1X Chininum Arsenicosum 4X 6X 8X 12X Hepar Sulphuris Calcareum 8X 10X 12X Hypericum Perforatum 3X Natrum Fluoratum 6X 8X 10X 12X Niccolum Metallicum 12X 15X Passiflora Incarnata 1X Sarsaparilla 2X Silicea 10X 12X 15X 20X Solidago Virgaurea 1X Thuja Occidentalis 6X 9X 12X Zincum Valerianicum 6X 9X 12X

Uses:

For temporary relief of minor:

irritability*

headache*

sadness*

recurrent nausea*

vomiting*

fear*

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritability, headache, sadness, recurrent nausea, vomiting, fear, or other symptoms do not improve within 7 days or are accompanied by fever.

Section 51945-4

FUTUREPLEX® N01

ANTITOX®

PROTOMER™

Homeopathic Formula

Irritability*

Headache* Sadness*

1 fl oz (30 mL)

Alcohol 20% by Volume

Section 53413-1

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55106-9

Active Ingredients

Adrenalinum

4C

Argentum Nitricum

6X 9X 12X 15X

Arnica Montana

3X 12X

Aurum Metallicum

12X 15X 20X 30X

Avena Sativa

1X

Berberis Vulgaris

1X

Chelidonium Majus

1X

Chininum Arsenicosum

4X 6X 8X 12X

Hepar Sulphuris Calcareum

8X 10X 12X

Hypericum Perforatum

3X

Natrum Fluoratum

6X 8X 10X 12X

Niccolum Metallicum

12X 15X

Passiflora Incarnata

1X

Sarsaparilla

2X

Silicea

10X 12X 15X 20X

Solidago Virgaurea

1X

Thuja Occidentalis

6X 9X 12X

Zincum Valerianicum

6X 9X 12X

Section 60561-8

Do not use if clear seal over the cap is broken or missing.

Directions:

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

alcohol (20% by volume), distilled water


Structured Label Content

Uses:

For temporary relief of minor:

irritability*

headache*

sadness*

recurrent nausea*

vomiting*

fear*

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritability, headache, sadness, recurrent nausea, vomiting, fear, or other symptoms do not improve within 7 days or are accompanied by fever.

Section 51945-4 (51945-4)

FUTUREPLEX® N01

ANTITOX®

PROTOMER™

Homeopathic Formula

Irritability*

Headache* Sadness*

1 fl oz (30 mL)

Alcohol 20% by Volume

Section 53413-1 (53413-1)

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active Ingredients

Adrenalinum

4C

Argentum Nitricum

6X 9X 12X 15X

Arnica Montana

3X 12X

Aurum Metallicum

12X 15X 20X 30X

Avena Sativa

1X

Berberis Vulgaris

1X

Chelidonium Majus

1X

Chininum Arsenicosum

4X 6X 8X 12X

Hepar Sulphuris Calcareum

8X 10X 12X

Hypericum Perforatum

3X

Natrum Fluoratum

6X 8X 10X 12X

Niccolum Metallicum

12X 15X

Passiflora Incarnata

1X

Sarsaparilla

2X

Silicea

10X 12X 15X 20X

Solidago Virgaurea

1X

Thuja Occidentalis

6X 9X 12X

Zincum Valerianicum

6X 9X 12X

Section 60561-8 (60561-8)

Do not use if clear seal over the cap is broken or missing.

Directions:

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

alcohol (20% by volume), distilled water


Advanced Ingredient Data


Raw Label Data

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