Proaller Solution/ Drops
FDA Label NDC 59469-116

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pekana Naturheilmittel for the product Proaller (NDC 59469-116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, dosage, warning, otc - keep out of reach of children, storage and handling, tamper evident, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Ingredients:
Ailanthus altissima4X
Euphrasia officinalis3X
Gratiola officinalis4X
Juglans regia6X
Okoubaka aubrevillei3X
Smilax (Sarsaparilla)8X
Taraxacum officinale12X

Selected ingredients prepared by spagyric processes.

Inactive Ingredient

Contains 28% alcohol by volume.

Otc - Purpose

For temporary relief of allergies and hay fever. 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.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Storage And Handling

Protect from light and heat.

Tamper Evident

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

Otc - Questions

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

Other

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

1.7 FL OZ
(50 ml)

PEKANA®

Principal Display Panel (50 ml Bottle Box)

Principal Display Panel (50 ml Bottle Box)

* Please review the disclaimer below.