PLEO UT- bacillus subtilis capsule

Pleo Ut by

Drug Labeling and Warnings

Pleo Ut 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 Analgesic Medicine

5 CAPSULES

Indications

For temporary pain relief of swollen lymph glands.

INGREDIENTS

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

OTHER COMPONENTS

Capsule shells consist of Hypromellose (HPMC).

DOSAGE

1–2 x 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.

SPL UNCLASSIFIED SECTION

Made in Germany

Manufactured by:
SANUM-Kehlbeck GmbH & Co. KG,
Hoya, Germany

Distributed by:
SANUM USA Corp.,
1465 Slater Road, Ferndale, WA 98248

Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 5 Capsules Carton

Pleo® Ut
CAPSULES 6X

Homeopathic
Analgesic Medicine

The original
SANUM™
brand remedies

Indications: For temporary pain
relief of swollen lymph glands.

5 CAPSULES

INGREDIENTS AND APPEARANCE

PLEO UT 
bacillus subtilis capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-5303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W)	bacillus subtilis	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: 60681-5303-2	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)