OKOUBAKA- okoubaka aubrevillei bark solution/ drops

OKOUBAKA by

Drug Labeling and Warnings

OKOUBAKA by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Natuheilmittel GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredients:
Okoubaka aubrevillei	2X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT

Contains 18% alcohol by volume.

Indications

For relief of occasional diarrhea. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Keep out of the reach of children.

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

QUESTIONS

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

OKOUBAKA™
Oral Drops

Homeopathic Medicine

For relief of
occasional diarrhea

1.7 FL OZ
(50 ml)

PEKANA®

INGREDIENTS AND APPEARANCE

OKOUBAKA 
okoubaka aubrevillei bark solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-032
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 50 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: 59469-032-10	1 in 1 BOX	04/12/2008
1		50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		04/12/2008

Labeler - PEKANA Natuheilmittel GmbH (320344542)

Establishment
Name	Address	ID/FEI	Business Operations
PEKANA Natuheilmittel GmbH		320344542	MANUFACTURE(59469-032)