PLEO REC- bacillus firmus capsule

Pleo Rec by

Drug Labeling and Warnings

Pleo Rec by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Fever Reducer Medicine

5 CAPSULES

Indications

For temporary relief of fever and minor inflammation.

INGREDIENTS

1 capsule contains: 330 mg Bacillus firmus 6X in a base of lactose.

DOSAGE

1–2x weekly 1 capsule.

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 taking 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 imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

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. 05/2007

PRINCIPAL DISPLAY PANEL - Capsule Carton

Pleo™ Rec
CAPSULES 4X

Homeopathic
Fever Reducer Medicine

Indications: For temporary relief
of fever and minor inflammation.

5 CAPSULES

INGREDIENTS AND APPEARANCE

PLEO REC 
bacillus firmus capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT)	bacillus firmus	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
lactose (UNII: J2B2A4N98G)
hypromellose (UNII: 3NXW29V3WO)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3103-2	1 in 1 CARTON
1		5 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/19/1996

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)