Allergy New England Mix Liquid
FDA Label NDC 43406-0106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Allergy New England Mix (NDC 43406-0106). 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, references, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, 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 - equal amounts of: Birch Mix 6X, Common Mugwort 6X, English Plantain 6X, Maple Mix, Oak Mix #2 6X, Pigweed Mix 6X, Pine Mix 6X, Ragweed Mix #2 6X, Red Cedar 6X, Red Mulberry 6X, Sheep Sorrel 6X, White Popular 6X.

Otc - Purpose

Uses:  Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies**.

References

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Indications & Usage

Uses:  Temporarily relieves sneezing, watery-itchy eyes, coughing, nasal congestion, runny nose &/or other symptoms related to outdoor allergies.**

Dosage & Administration

Directions:  Adults & children above 12 years, spray 2 full sprays under the tongue 3 times daily, or as directed by a health care professional.

Otc - Keep Out Of Reach Of Children

WARNINGS:

         * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

         * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get      

            medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

         * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

         * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get      

            medical help or contact a Poison Control Center right away.

         * Do not us if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

Inactive Ingredients:  Citric Acid, Ethyl Alcohol USP, Glycerin USP, Purified Water.

Otc - Do Not Use

Other Information:  Tamper Seal:  “Sealed for your protection.”   Do not use if TAMPER EVIDENT seal is broken or missing.

Otc - Questions

Questions & Comments?:  Natural Creations, Inc. / Woodbine, IA 51579 / 712.647.1600

Package Label.Principal Display Panel

NDC:  43406-0106-1

ALLERGY

NEW ENGLAND MIX

Outdoor Allergy Symptoms**

HOMEOPATHIC

1 fl oz (30 mL)/10%

 GMP Logo  UPC:  877730003843  NON GMO Logo

* Please review the disclaimer below.