PLEO OKU- okoubaka aubrevillei bark tablet

Pleo Oku by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Homeopathic Antidiarrheal Medicine

Indications

For temporary relief of acute diarrhea.

ACTIVE INGREDIENT

INGREDIENTS

One tablet contains 250 mg Okoubaka aubrevillei 2X in a base of lactose, potato starch, magnesium stearate.

Tamper Evident

Do not use this product if imprinted inner blister pack is broken.

DOSAGE

Acute

1 tablet every half to full hour up to a max. of 12 times daily.

Chronic

2 tablets daily.

WARNING

lf 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 other 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

Protect from light and heat.

SPL UNCLASSIFIED SECTION

Rev. 04/2012

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

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

PRINCIPAL DISPLAY PANEL - 80 Tablet Carton

Pleo® Oku
TABLETS 2X

Homeopathic
Antidiarrheal
Medicine

The original
SANUM®

brand remedies

Indications: For temporary relief of
acute diarrhea.

80 TABLETS

INGREDIENTS AND APPEARANCE

PLEO OKU 
okoubaka aubrevillei bark tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2402
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z)	OKOUBAKA AUBREVILLEI BARK	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
STARCH, POTATO (UNII: 8I089SAH3T)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2402-2	8 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		07/10/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
Sanum-Kehlbeck GmbH & Co. KG		318386133	MANUFACTURE(60681-2402)