Allergy South East Mix Liquid
FDA Label NDC 43406-0223

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 South East Mix (NDC 43406-0223). 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, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, 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 amount of: Birch mix 6X, Common Mugwort 6X, English Plantain 6X, Maple Mix 6X, Oak Mix #2 6X, Pigweed Mix 6X, Pine Mix 6X, Ragweed Mix #2 6X, Red Cedar 6X, Red Mulberry 6X, Sheep Sorrel 6X,  White Poplar 6X.

Indications & Usage

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

Otc - Purpose

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

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:

  • Consult a physician for use in children under 12 years of age.
  • 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 use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Citric Acid, Ethyl Alcohol USP, Glycerin USP, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Package Label.Principal Display Panel

NDC: 43406-0223-1

ALLERGY SOUTH EAST MIX

HOMEOPATHIC

1 fl oz (30 mL) / 10% Alcohol

877730004321

* Please review the disclaimer below.