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  5. Label Information: Oral Soothe

FDA Label for Oral Soothe

View Indications, Usage & Precautions

Table of Contents

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

Oral Soothe Product Label

The following document was submitted to the FDA by the labeler of this product Feelgood Health. 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 - Purpose



Relieves pain, crankiness and crying during teething


Indications & Usage



Indications:  Soothing homeopathic remedy for teething in babies and children.


Dosage & Administration



Dosage: Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.


General Precautions



Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.


Otc - Active Ingredient



Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)


Inactive Ingredient



Sucrose (inactive ingredient).


Warnings



Contains no gluten, artificial flavors, colors or preservatives.Safe for all ages.


Information For Patients



All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.


Package Label.Principal Display Panel



bottle label - OralSoothe

bottle label - OralSoothe


Otc - Keep Out Of Reach Of Children



Keep this and all medicines from the reach of children.


* Please review the disclaimer below.