Pleo™ Fort DROPS 5X

Manufacturer: Sanum-Kehlbeck GmbH & Co. KG
Effective date: 2009-09-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:55

Label at a glance#

ProductPleo Fort

Active ingredientpenicillium roqueforti

Label structure10 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Digestive Aid Medicine

Indications

INDICATIONS & USAGE SECTION

For temporary relief of digestive symptoms such as fullness, pressure, or "gas" that occur after eating.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL Penicillium roquefortii 5X 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

5–10 drops, once daily.

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. 12/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Fort DROPS 5X

Homeopathic Digestive Aid Medicine

Indications: For temporary relief of digestive symptoms such as
fullness, pressure, or "gas" that occurs after eating.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, once daily. 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 Penicillium
roquefortii 5X in a base of purified water.
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Fort
DROPS 5X

Homeopathic
Digestive Aid
Medicine

lndications: For
temporary relief
of digestive
symptoms such
as fullness,
pressure, or
"gas" that occur
after eating.

ORIGINAL ENDERLEIN

0.34 fl oz
(10 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-1101-1	2019-10-21	C162847	48780-1	956f9ecf-ce10-621f-e053-dbdaa90a74ad	Pleo™ Fort DROPS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-1101-1	Pleo Fort	1 in 1 CARTON	SOLUTION/ DROPS	1		1
60681-1101-1	Pleo Fort	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-1101	PLEO FORT (PENICILLIUM ROQUEFORTI) SOLUTION/ DROPS [SANUM-KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_a6daae70-084a-4625-b621-29fc568d0386.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
penicillium roqueforti	ACTIVE INGREDIENT	7ORP6R724L	1
penicillium roqueforti	ACTIVE MOIETY	7ORP6R724L	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Pleo Fort
penicillium roqueforti
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-1101	60681-1101-1

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
Name	UNII	Kind
penicillium roqueforti	7ORP6R724L	ACTIB
water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f9c345ae-2c9b-4df3-9395-9ccbb8f02184			a6daae70-084a-4625-b621-29fc568d0386	2009-09-21	Warnings	Exact identifier spl id: f9c345ae-2c9b-4df3-9395-9ccbb8f02184 spl set id: a6daae70-084a-4625-b621-29fc568d0386

Reported adverse events (FAERS/openFDA)#

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