Allersode
FDA Label NDC 57520-0522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Allersode (NDC 57520-0522). 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, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Allium cepa3X, Ambrosia artemisiaefolia 3X, Euphrasia officinalis 3X, Sabadilla 6X, Glandula suprarenalis suis 6X, 10X, 24X, Hepar suis 6X, 10X, 24X, Histaminum hydrochloricum 6X, 12X, 30X, Arsenicum album 12X, Phosphorus 12X, Pulsatilla 12X, Sulphur 12X, (Tree Mixture) Ash 6X, 8X, 26X, American elm 6X, 8X, 26X, American sycamore 6X, 8X, 26X, Beech 6X, 8X, 26X, Black walnut 6X, 8X, 26X, Black willow 6X, 8X, 26X, Box elder 6X, 8X, 26X, Eastern cottonwood 6X, 8X, 26X, Red Birch 6X, 8X, 26X, Red oak 6X, 8X, 26X, Shagbark hickory 6X, 8X, 26X, (Grass Mixture) Kentucky bluegrass 6X, 8X, 26X, Orchard 6X, 8X, 26X, Redtop 6X, 8X, 26X, (Ragweed Mixture) Giant ragweed 6X, 8X, 26X, False ragweed 6X, 8X, 26X, Short ragweed 6X, 8X, 26X, Western ragweed 6X, 8X, 26X, (Sorrel Mixture) Sheep sorrel 6X, 8X, 26X, Yellow dock 6X, 8X, 26X.



Otc - Purpose

INDICATIONS:  Assists in the management of inhalent allergies.

Warnings

WARNINGS:  Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Do not use if tamper evident seal is broken or missing.



Dosage & Administration

DIRECTIONS:  10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.


Inactive Ingredient

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


Otc - Questions

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322



For a complete list of Pollen Isodes contact Synergy Formulas, Inc.


Package Label.Principal Display Panel

Synergy Formulas

ALLERSODE II

HOMEOPATHIC

2 FL OZ (60 ml)

Allersode Ii (Mm1)

Allersode Ii (Mm1)

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