Prunus Spinosa

Manufacturer
True Botanica, LLC
Effective date
2023-05-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:32:03

Label at a glance#

ProductPrunus Spinosa
Active ingredientPRUNUS SPINOSA FLOWER BUD
Label structure11 sections

Dosage and administration

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Prunus Spinosa 6X, HPUS

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Use as a refreshing, restoring tonic. Especially with exhaustion. May also be used for standard homeopathic indications or as directed by your physician.

Use:

INDICATIONS & USAGE SECTION

Use as a refreshing, restoring tonic. Especially with exhaustion. May also be used for standard homeopathic indications or as directed by your physician.

Warnings:

WARNINGS SECTION

Consult your health care provider if symptoms persist more than 5 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - DO NOT USE SECTION

TAMPER EVIDENT: Do not use if safety seal is broken before first use.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Sucrose

OTC - QUESTIONS SECTION

Developed and Made by

True Botanica, LLC

1005 Richards Rd., Suite D

Hartland, WI 53029

800-315-8783

www.truebotanica.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prunus Spinosa 6XPrunus Spinosa 6X

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-1550-22021-01-31C16284748780-1ba0f9c33-2acd-a910-e053-dadaa90a0b85Prunus Spinosa 6X
53645-1550-22021-01-29C16284748780-1ba0f9c33-2acd-a910-e053-dadaa90a0b85Prunus Spinosa 6X

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1550PRUNUS SPINOSA GLOBULE [TRUE BOTANICA, LLC]5Legacy NDC20230502_6196702b-d836-05ab-e053-2991aa0a451e.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53645-155053645-1550-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
PRUNUS SPINOSA FLOWER BUD53Y84VPS2WACTIB

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
458696c6-881c-d85c-e063-6294a90ac1196196702b-d836-05ab-e053-2991aa0a451e2025-12-09WarningsExact identifier
spl set id: 6196702b-d836-05ab-e053-2991aa0a451e

Reported adverse events (FAERS/openFDA)#

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