PLEO UT- bacillus subtilis capsule 
Sanum Kehlbeck GmbH & Co. KG

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Pleo™ Ut
CAPSULES 4X

Homeopathic Analgesic Medicine

5 CAPSULES

Indications

For temporary pain relief of swollen lymph glands.

INGREDIENTS

1 capsule contains 330 mg Bacillus subtilis 4X in a base of lactose.

OTHER COMPONENTS

Capsule shells consist of Hypromellose (HPMC).

DOSAGE

1–2 capsules 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.

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 - 5 Capsules Carton

Pleo™ Ut
CAPSULES 4X

Homeopathic
Analgesic Medicine

Indications: For temporary pain
relief of swollen lymph glands.

5 CAPSULES

Principal Display Panel - 5 Capsules Carton
PLEO UT 
bacillus subtilis capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W) bacillus subtilis4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
lactose (UNII: J2B2A4N98G)  
hypromellose (UNII: 3NXW29V3WO)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-5302-21 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 10/2009
Document Id: 8c87f0eb-b4a4-4ae4-965e-07b2280907d9
Set id: 01ca3cf1-e284-4699-bc3f-3d18bcd4c5ef
Version: 1
Effective Time: 20091008
 
Sanum Kehlbeck GmbH & Co. KG