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 4X in a base of lactose.

OTHER COMPONENTS

Capsule shells consist of Hypromellose (HPMC).

DOSAGE

1–2 times weekly, one capsule either before breakfast or at bedtime.

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 shrink-wrap is missing from the carton or the imprinted blister foil is broken.

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. 12/2004

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: 60681-3102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT)	bacillus firmus	4 [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: 60681-3102-2	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)