Prostatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:36:50

Label at a glance#

ProductProstatone
Active ingredientCHIMAPHILA UMBELLATA, HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CLEMATIS RECTA FLOWERING TOP, CONIUM MACULATUM FLOWERING TOP, CHONDRODENDRON TOMENTOSUM ROOT, PULSATILLA PRATENSIS, THUJA OCCIDENTALIS LEAFY TWIG, ELYMUS REPENS ROOT, DELPHINIUM STAPHISAGRIA SEED, ZINC
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Chimaphila Umbellata 3X, Hydrangea Arborescens 3X, Sabal Serrulata 3X, Clematis Erecta 12X, Conium Maculatum 12X, Pareira Brava 12X, Pulsatilla (Pratensis) 12X, Thuja Occidentalis 12X, Triticum Occidentalis 12X, Triticum Repens 12X, Staphysagria 12X, Zincum Metallicum 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of pain down thighs during efforts to urinate, great straining and constant urging when urinating.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

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

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 broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of pain down thighs during efforts to urinate, great straining and constant urging when urinating.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579   800.868.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

PROSTATONE

1 fl. oz. (30 ml)

ProstatoneProstatone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0311-12020-04-08C16284748780-19d75b9d0-d645-f424-e053-dadaa90a57ceDrug Facts:
44911-0311-12020-01-31C16284748780-19d75b9d0-d645-f424-e053-dadaa90a57ceDrug Facts:

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
44911-031144911-0311-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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
50bc34c8-0465-4277-b6bf-7366590145b4a2b71d89-06d5-4db8-9cef-5598e0fcf1472020-04-08WarningsExact identifier
spl id: 50bc34c8-0465-4277-b6bf-7366590145b4
spl set id: a2b71d89-06d5-4db8-9cef-5598e0fcf147

Reported adverse events (FAERS/openFDA)#

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