PROALLER- ailanthus altissima whole, okoubaka aubrevillei bark, euphrasia stricta, gratiola officinalis, juglans regia whole, smilax regelii root, and taraxacum officinale whole solution/ drops

PROALLER by

Drug Labeling and Warnings

PROALLER by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Naturheilmittel. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredients:
Ailanthus altissima	4X
Euphrasia officinalis	3X
Gratiola officinalis	4X
Juglans regia	6X
Okoubaka aubrevillei	3X
Smilax (Sarsaparilla)	8X
Taraxacum officinale	12X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT

Contains 28% alcohol by volume.

Indications

For temporary relief of allergies and hay fever symptoms. 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

PROALLER™
Oral Drops

Homeopathic Medicine

For temporary relief
of allergies and
hay fever symptoms

1.7 FL OZ
(50 ml)

PEKANA®

INGREDIENTS AND APPEARANCE

PROALLER 
ailanthus altissima whole, okoubaka aubrevillei bark, euphrasia stricta, gratiola officinalis, juglans regia whole, smilax regelii root, and taraxacum officinale whole solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ailanthus altissima Whole (UNII: 5G78C6GB5E) (Ailanthus altissima Whole - UNII:5G78C6GB5E)	Ailanthus altissima Whole	4 [hp_X]  in 50 mL
Okoubaka aubrevillei Bark (UNII: MK2074187Z) (Okoubaka aubrevillei Bark - UNII:MK2074187Z)	Okoubaka aubrevillei Bark	3 [hp_X]  in 50 mL
Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL)	Euphrasia Stricta	3 [hp_X]  in 50 mL
Gratiola officinalis (UNII: BDD9991A36) (Gratiola officinalis - UNII:BDD9991A36)	Gratiola officinalis	4 [hp_X]  in 50 mL
Juglans regia Whole (UNII: 87EJ76IO83) (Juglans regia Whole - UNII:87EJ76IO83)	Juglans regia Whole	6 [hp_X]  in 50 mL
Smilax Ornata Root (UNII: 2H1576D5WG) (Smilax Ornata Root - UNII:2H1576D5WG)	Smilax Ornata Root	8 [hp_X]  in 50 mL
Taraxacum officinale Whole (UNII: 7C42E2D7B0) (Taraxacum Officinale Whole - UNII:7C42E2D7B0)	Taraxacum officinale Whole	12 [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: 59469-116-10	1 in 1 BOX	12/11/2008
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		12/11/2008

Labeler - PEKANA Naturheilmittel (320344542)

Establishment
Name	Address	ID/FEI	Business Operations
PEKANA Naturheilmittel		320344542	MANUFACTURE(59469-116)