FDA.reportPublic FDA data

No More Monsters

Manufacturer
NaturalCare | Apotheca Company
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:37:57

Label at a glance#

ProductNo More Monsters
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, DIBASIC POTASSIUM PHOSPHATE, LYCOPODIUM CLAVATUM SPORE, PASSIFLORA INCARNATA FLOWERING TOP, GALLIC ACID MONOHYDRATE
Label structure9 sections

Indications and uses

May help temporarily relieve ■ frightful dreams ■ sleeplessness ■ frequent waking* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

■ children 4 years and over take 3 chewable tablets in mouth prior to bedtime and again at bedtime.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

(in each tablet) Gallicum Acidum 6X 0.025%, Kali Phosphoricum 6X 0.025%, Lycopodium Clavatum 6X 0.025%, Passiflora Incarnata 4X 0.025%, Calcarea Carbonica 6X 0.001%.

PURPOSE

OTC - PURPOSE SECTION

Gallicum Acidum – fear of the dark, Kali Phosphoricum - anxiety, Lycopodium Clavatum – overactive mind, Passiflora Incarnata - anxiety, Calcarea Carbonica – frequent waking, frightful dreams*

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

USES:

INDICATIONS & USAGE SECTION

May help temporarily relieve ■ frightful dreams ■ sleeplessness ■ frequent waking*

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if

■ symptoms worsen or continue for more than 10 days

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 missing or open.

■ Store tightly closed at room temperature (65-80ºF)

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

■ children 4 years and over take 3 chewable tablets in mouth prior to bedtime and again at bedtime.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose, natural banana flavor

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By NaturalCare

201 Apple Blvd.

Woodbine, IA 51579

www.NaturalCareWorks.com

1-888-280-5672

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NaturalCare

children's

No More Monsters

For Peaceful Sleep

Homeopathic

125 Mini Tablets

No More Monsters LBLNo More Monsters LBL

No More Monsters CTNNo More Monsters CTN

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130701619178493GTIN-13: 0701619178493
EAN-13: 0701619178493
GTIN-12: 701619178493
UPC-A: 701619178493
GTIN storage (14 digits): 00701619178493		NACA0010 No More Monsters LBLCPY 7-14-25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70163-0010-1No More Monsters125 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1251
70163-0010-2No More Monsters1 in 1 CARTONTABLET, CHEWABLE11

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70163-001070163-0010-1, 70163-0010-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
GALLIC ACID MONOHYDRATE48339473OTACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
No More MonstersCALCAREA CARBONICA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PASSIFLORA INCARNATA, GALLICUM ACIDUMNaturalCarec28be233-b4d1-42c6-bc63-3cd276aec5bb2026-03-10WarningsExact identifier
ndc (package): 70163-0010-2
ndc (package): 70163-0010-1
ndc (product): 70163-0010
ndc11 (package): 70163001002
ndc11 (package): 70163001001
spl id: 1ed33932-a6d5-4d51-b077-f36ed2dc6548
spl set id: c28be233-b4d1-42c6-bc63-3cd276aec5bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.