FDA.reportPublic FDA data

Pleo™ Relivora DROPS 2X, 3X, 4X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2009-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:01

Label at a glance#

ProductPleo Relivora
Active ingredientdrosera rotundifolia, echinacea angustifolia root, english walnut
Label structure8 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

1 fl oz
(30 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of coughs and symptoms of bronchitis.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

30 mL contains 0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X, water, ethanol (28%).

Tamper Evident

OTC - DO NOT USE SECTION

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Acute

SPL UNCLASSIFIED SECTION

15 drops every two hours, up to 6 times daily.

Chronic

SPL UNCLASSIFIED SECTION

20-25 drops, 3 times daily, unless otherwise recommended by your health care professional.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING SECTION

Protect from light and heat.

SPL UNCLASSIFIED SECTION

Made in Germany.

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 08/2007

PRINCIPAL DISPLAY PANEL - 30 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Relivora DROPS 2X , 3X, 4X

Homeopathic Medicine

Indications: For temporary relief of coughs and symptoms of bronchitis.

1 fl oz (30 mL)

DOSAGE: Acute: 15 drops every 2 hours, up to 6 times daily. Chronic: 20-25 drops, 3 times daily,
unless otherwise recommended by your health care professional. WARNING: If symptoms persist,
contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice
of a health care professional before using this product. Keep this and all medications out of the
reach of children. In case of accidental overdose, seek professional assistance or contact a Poison
Control Center immediately. Protect from light and heat. TAMPER EVIDENT: Do not use this product
if tamper-evident seal on base of bottle cap is missing or broken. INGREDIENTS: 30 mL contains:
0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X in a base of purified
water, ethanol (28 %).
Rev. 06/2009

Principal Display Panel
Principal Display Panel

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-6200-32019-10-21C16284748780-1956f9ecf-de9c-621f-e053-dbdaa90a74adPleo™ Relivora DROPS 2X, 3X, 4X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-6200-3Pleo Relivora30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
60681-6200-3Pleo Relivora1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-6200PLEO RELIVORA (DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA ROOT AND ENGLISH WALNUT) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]2Legacy NDC, 2 package rows20110114_125e34ec-c7d2-4801-bbc7-9c72784545d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
drosera rotundifoliaACTIVE INGREDIENT75O014T1HG2
echinacea angustifolia rootACTIVE INGREDIENTD982V7VT3P2
english walnutACTIVE INGREDIENT1V3SHR7QB72
drosera rotundifoliaACTIVE MOIETY75O014T1HG2
echinacea angustifolia rootACTIVE MOIETYD982V7VT3P2
english walnutACTIVE MOIETY1V3SHR7QB72
alcoholINACTIVE INGREDIENT3K9958V90M2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60681-620060681-6200-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
drosera rotundifolia75O014T1HGACTIB
echinacea angustifolia rootD982V7VT3PACTIB
english walnut1V3SHR7QB7ACTIB
water059QF0KO0RIACT
alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates

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
5b89aff2-2715-4732-aef1-73cada3ca3d0125e34ec-c7d2-4801-bbc7-9c72784545d82009-11-30WarningsExact identifier
spl id: 5b89aff2-2715-4732-aef1-73cada3ca3d0
spl set id: 125e34ec-c7d2-4801-bbc7-9c72784545d8

Reported adverse events (FAERS/openFDA)#

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