Pleo™ Rec DROPS 6X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-09-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:59

Label at a glance#

ProductPleo Rec

Active ingredientBACILLUS FIRMUS

Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Fever Reducer Medicine

0.17 fl oz
(5 mL)

Indications

INDICATIONS & USAGE SECTION

For temporary relief of fever and minor inflammation.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

5 mL Bacillus firmus 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

2–5 drops, 1–3 times weekly before mealtime.

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. 05/2006

PRINCIPAL DISPLAY PANEL - 5 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Rec DROPS 6X

Homeopathic Fever Reducer Medicine

Indications: For temporary relief of fever and minor inflammation.

0.17 fl oz (5 mL)

DOSAGE: 1-3x weekly 2-5 drops before mealtime. 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 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: 5 mL Bacillus firmus 6X in a base of purified water.
Rev. 06/2009

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-3101-2	2019-10-21	C162847	48780-1	956f9ecf-c96f-621f-e053-dbdaa90a74ad	Pleo™ Rec DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-3101-2	Pleo Rec	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		1
60681-3101-2	Pleo Rec	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-3101	PLEO REC (BACILLUS FIRMUS) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_eccda292-6e04-4c12-8e40-c7aa5ac488b4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACILLUS FIRMUS	ACTIVE INGREDIENT	D6U864H4DT	1
BACILLUS FIRMUS	ACTIVE MOIETY	D6U864H4DT	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 Rec
BACILLUS FIRMUS
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-3101	60681-3101-2

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
BACILLUS FIRMUS	D6U864H4DT	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
710a9906-e7bb-49e1-986e-a15eff2bf99a			eccda292-6e04-4c12-8e40-c7aa5ac488b4	2009-09-30	Warnings	Exact identifier spl id: 710a9906-e7bb-49e1-986e-a15eff2bf99a spl set id: eccda292-6e04-4c12-8e40-c7aa5ac488b4

Reported adverse events (FAERS/openFDA)#

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