W04

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:30

Label at a glance#

ProductW04 NEUROCALM
Active ingredientHYPERICUM PERFORATUM, POTASSIUM PHOSPHATE, DIBASIC, MATRICARIA CHAMOMILLA, ESCHSCHOLZIA CALIFORNICA, PASSIFLORA INCARNATA TOP, VALERIAN, HOPS, PHOSPHORUS, PULSATILLA VULGARIS, ZINC VALERATE DIHYDRATE, AMERICAN GINSENG, AVENA SATIVA FLOWERING TOP, COFFEA ARABICA SEED, ROASTED, GLYCYRRHIZA GLABRA
Label structure7 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

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.

Warnings:

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTHER SAFETY INFORMATION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - STOP USE SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® W04

ANTITOX®

NEUROCALM™

Homeopathic Formula

Nervous Irritability*

Restlessness* Headache*

2 fl oz (60 mL)

Alcohol 20% by Volume

W04 Neurocalm 20210208 label.jpgW04 Neurocalm 20210208 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-2304-1W04NEUROCALM60 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-2304W04 NEUROCALM (AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bf50b27a-e6d0-5393-e053-2995a90a1dff.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-230463479-2304-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
W04 NEUROCALMAMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUMApex Energetics Inc.bf50b27a-e6d0-5393-e053-2995a90a1dff2024-01-08WarningsExact identifier
ndc (package): 63479-2304-1
ndc (product): 63479-2304
ndc11 (package): 63479230401
spl id: 0e7729de-1053-e578-e063-6394a90a7de6
spl set id: bf50b27a-e6d0-5393-e053-2995a90a1dff