FDA.reportPublic FDA data

JUVE-CAL

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:37

Label at a glance#

ProductJUVE-CAL
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, PHOSPHORIC ACID, SILVER NITRATE, BARIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, DELPHINIUM STAPHISAGRIA SEED, CALCIUM HYPOPHOSPHITE, CINCHONA OFFICINALIS BARK
Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ingredients:
Artemisia abrotanum (Abrotanum)8X
Acidum phosphoricum4X
Argentum nitricum6X
Barium carbonicum12X
Calcium hypophosphoricum4X
Cinchona succirubra (China)8X
Delphinium staphysagria6X
Lycopodium clavatum (Lycopodium)12X

INACTIVE INGREDIENT SECTION

In a base of Vinum liquorosum. Selected ingredients prepared by spagyric processes.

Contains 19% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For occasional minor fatigue and exhaustion. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 1 to 2 teaspoons, 2 to 3 times per day, measured in a calibrated dosing cup. For pediatric doses, consult your practitioner.

Warning

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper evident strip is broken or removed from base of cap.

OTC - QUESTIONS SECTION

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JUVE-CAL™

Oral Drops

Homeopathic Medicine

For occasional minor
fatigue and exhaustion

8.5 fl. oz. (250ml)

PEKANA®

Principal Display Panel - 250 ml Bottle Box
Principal Display Panel - 250 ml Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-310-50JUVE-CAL1 in 1 BOXSYRUP13
59469-310-50JUVE-CAL250 mL in 1 BOTTLE, GLASSSYRUP2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-310JUVE-CAL (ARTEMISIA ABROTANUM FLOWERING TOP, PHOSPHORIC ACID, SILVER NITRATE, BARIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, DELPHINIUM STAPHISAGRIA SEED, CALCIUM HYPOPHOSPHITE, AND CINCHONA OFFICINALIS BARK) SYRUP [PEKANA NATURHEILMITTEL GMBH]3Current NDC, Legacy NDC, 2 package rows20230113_df17fb22-d710-4d97-897d-c1f6aabdecbc.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-31059469-310-50

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
ARTEMISIA ABROTANUM FLOWERING TOPQG07G580U0ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SILVER NITRATE95IT3W8JZEACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
CALCIUM HYPOPHOSPHITECUI83R2732ACTIM
CINCHONA OFFICINALIS BARKS003A158SBACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
JUVE-CALARTEMISIA ABROTANUM FLOWERING TOP, PHOSPHORIC ACID, SILVER NITRATE, BARIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, DELPHINIUM STAPHISAGRIA SEED, CALCIUM HYPOPHOSPHITE, AND CINCHONA OFFICINALIS BARKPEKANA Naturheilmittel GmbHdf17fb22-d710-4d97-897d-c1f6aabdecbc2023-01-11WarningsExact identifier
ndc (package): 59469-310-50
ndc (product): 59469-310
ndc11 (package): 59469031050
spl id: 2ac5dadc-a1d4-4f2b-a6a3-a2ec087429c4
spl set id: df17fb22-d710-4d97-897d-c1f6aabdecbc

Reported adverse events (FAERS/openFDA)#

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