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  5. Label Information: Allergy South East Mix

FDA Label for Allergy South East Mix

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy South East Mix Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.