PLEO OKU- okoubaka aubrevillei bark solution/ drops

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]

SPL UNCLASSIFIED SECTION

Homeopathic
Antidiarrheal
Medicine

1 fl oz
(30 mL)

Indications

For temporary relief of acute diarrhea.

INGREDIENTS

30 mL Okoubaka aubrevillei 2X in a base of purified water, ethanol (70%).

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

DOSAGE

Acute

5 drops, every ½ to 1 hour;

Chronic

5 drops, 1-3 times daily.

WARNING

lf symptoms persist more than a few days, contact a licensed practitioner. As with any other 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 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

Made in Germany.

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

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev.12/2007

PRINCIPAL DISPLAY PANEL - 30 mL Label

Pleo™ Oku DROPS 2X

Homeopathic Antidiarrheal Medicine

Indications: For temporary relief of acute diarrhea.

1 fl oz (30 mL)

DOSAGE: Acute: 5 drops every ½ to 1 hour; Chronic: 5 drops, 1–3 times daily. WARNING:
If symptoms persist more than a few days, contact a licensed practitioner. As with any other
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 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
tamper-evident seal on base of bottle cap is missing or broken. INGREDIENTS: 30 mL
contains: Okoubaka aubrevillei 2X in a base of purified water, ethanol (70 %). Rev. 06/2009

INGREDIENTS AND APPEARANCE

PLEO OKU 
okoubaka aubrevillei bark solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2401
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]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2401-3	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

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)