Pleo™ San COLI DROPS 6X

Manufacturer
Sanum Kehlbeck GmbH & Co. KG
Effective date
2009-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:56

Label at a glance#

ProductPleo San Coli
Active ingredientescherichia coli
Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of gastroenteritis symptoms.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL Escherichia coli 6X in a base of purified water.

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

1-2× daily 5-10 drops.

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 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. 02/2008

PRINCIPAL DISPLAY PANEL - 10 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ San COLI DROPS 6X

Homeopathic Medicine

Indications: For temporary relief of gastroenteritis symptoms.

0.34 fl oz (10 mL)

DOSAGE: 1–2 × daily 5–10 drops. WARNING: 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. 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: 10 mL Escherichia
coli 6X in a base of purified water.
Rev. 06/2009

Principal Display Panel 10 mL Label
Principal Display Panel 10 mL Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60681-1224-12019-10-21C16284748780-1956f9ecf-c0f6-621f-e053-dbdaa90a74adPleo™ San COLI DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60681-1224-1Pleo San Coli1 in 1 CARTONSOLUTION/ DROPS11
60681-1224-1Pleo San Coli10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60681-1224PLEO SAN COLI (ESCHERICHIA COLI) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]1Legacy NDC, 2 package rows20110113_bd67af2c-5993-485f-beb0-44f15863d771.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
escherichia coliACTIVE INGREDIENT514B9K0L101
escherichia coliACTIVE MOIETY514B9K0L101
waterINACTIVE INGREDIENT059QF0KO0R1

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
60681-122460681-1224-1

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
escherichia coli514B9K0L10ACTIB
water059QF0KO0RIACT

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
9c1c2e3d-614d-4e8e-97be-a8767c140297bd67af2c-5993-485f-beb0-44f15863d7712009-10-01WarningsExact identifier
spl id: 9c1c2e3d-614d-4e8e-97be-a8767c140297
spl set id: bd67af2c-5993-485f-beb0-44f15863d771

Reported adverse events (FAERS/openFDA)#

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