UPELVA

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:33

Label at a glance#

ProductUPELVA
Active ingredientCYCLAMEN PURPURASCENS TUBER, CHAMAELIRIUM LUTEUM ROOT, HYPERICUM PERFORATUM WHOLE, POTASSIUM CARBONATE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM FLOWERING TOP, VIBURNUM OPULUS BARK, ZANTHOXYLUM AMERICANUM BARK
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ingredients:
Cyclamen europaeum3X
Datura stramonium (Stramonium)10X
Delphinium staphysagria (Staphisagria)6X
Chamaelirium luteum (Helonias dioica)4X
Hypericum perforatum3X
Kalium carbonicum4X
Zanthoxylum fraxineum (Xanthoxylum fraxineum)3X
Viburnum opulus1X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT SECTION

Contains 44% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For relief of minor menstrual pain. 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 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

WARNINGS 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 - 50 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UPELVA™

Oral Drops

Homeopathic Medicine

For relief of minor
menstrual pain

1.7 FL OZ
(50 ml)

PEKANA®

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-319-10UPELVA50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-319-10UPELVA1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-319UPELVA (CYCLAMEN PURPURASCENS TUBER, CHAMAELIRIUM LUTEUM ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM FLOWERING TOP, VIBURNUM OPULUS BARK, AND ZANTHOXYLUM AMERICANUM BARK) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_0eb375d3-a0bb-4592-a2eb-6553f024d78c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-31959469-319-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
UPELVACYCLAMEN PURPURASCENS TUBER, CHAMAELIRIUM LUTEUM ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM FLOWERING TOP, VIBURNUM OPULUS BARK, AND ZANTHOXYLUM AMERICANUM BARKPEKANA Naturheilmittel GmbH0eb375d3-a0bb-4592-a2eb-6553f024d78c2023-01-11WarningsExact identifier
ndc (package): 59469-319-10
ndc (product): 59469-319
ndc11 (package): 59469031910
spl id: 25975778-438f-499f-9f7d-ee6697c6a18f
spl set id: 0eb375d3-a0bb-4592-a2eb-6553f024d78c

Reported adverse events (FAERS/openFDA)#

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