W04

W04
SPL v2
SPL
SPL Set ID bf50b27a-e6d0-5393-e053-2995a90a1dff
Route
SUBLINGUAL
Published
Effective Date 2021-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypericum Perforatum (3 [hp_X]) Potassium Cation (9 [hp_X]) Matricaria Chamomilla (1 [hp_X]) Eschscholzia Californica (10 [hp_X]) Passiflora Incarnata Top (12 [hp_X]) Valerian Hops Phosphorus Pulsatilla Vulgaris Valeric Acid American Ginseng Avena Sativa Flowering Top Coffea Arabica Seed, Roasted Glycyrrhiza Glabra
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1994-08-15

Description

Active Ingredients American Ginseng 1X Avena Sativa 1X Chamomilla 3X Coffea Tosta 6X 8X 10X 12X Eschscholtzia Californica 1X Glycyrrhiza Glabra 1X Humulus Lupulus 1X Hypericum Perforatum 3X Kali Phosphoricum 9X Passiflora Incarnata 1X Phosphorus 10X Pulsatilla Vulgaris 6X 9X 12X Valeriana Officinalis 1X Zincum Valerianicum 6X 9X 12X


Medication Information

Description

Active Ingredients American Ginseng 1X Avena Sativa 1X Chamomilla 3X Coffea Tosta 6X 8X 10X 12X Eschscholtzia Californica 1X Glycyrrhiza Glabra 1X Humulus Lupulus 1X Hypericum Perforatum 3X Kali Phosphoricum 9X Passiflora Incarnata 1X Phosphorus 10X Pulsatilla Vulgaris 6X 9X 12X Valeriana Officinalis 1X Zincum Valerianicum 6X 9X 12X

Uses:

For temporary relief of minor:

nervous irritability*

restlessness*

headache*

anxiety*

sweet craving*

*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 nervous irritability, restlessness, headache, anxiety, sweet craving, or other symptoms do not improve within 7 days or are accompanied by fever.

Section 51945-4

FUTUREPLEX® W04

ANTITOX®

NEUROCALM™

Homeopathic Formula

Nervous Irritability*

Restlessness* Headache*

2 fl oz (60 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

American Ginseng

1X

Avena Sativa

1X

Chamomilla

3X

Coffea Tosta

6X 8X 10X 12X

Eschscholtzia Californica

1X

Glycyrrhiza Glabra

1X

Humulus Lupulus

1X

Hypericum Perforatum

3X

Kali Phosphoricum

9X

Passiflora Incarnata

1X

Phosphorus

10X

Pulsatilla Vulgaris

6X 9X 12X

Valeriana Officinalis

1X

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 15 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:

nervous irritability*

restlessness*

headache*

anxiety*

sweet craving*

*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 nervous irritability, restlessness, headache, anxiety, sweet craving, or other symptoms do not improve within 7 days or are accompanied by fever.

Section 51945-4 (51945-4)

FUTUREPLEX® W04

ANTITOX®

NEUROCALM™

Homeopathic Formula

Nervous Irritability*

Restlessness* Headache*

2 fl oz (60 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

American Ginseng

1X

Avena Sativa

1X

Chamomilla

3X

Coffea Tosta

6X 8X 10X 12X

Eschscholtzia Californica

1X

Glycyrrhiza Glabra

1X

Humulus Lupulus

1X

Hypericum Perforatum

3X

Kali Phosphoricum

9X

Passiflora Incarnata

1X

Phosphorus

10X

Pulsatilla Vulgaris

6X 9X 12X

Valeriana Officinalis

1X

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 15 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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