FDA Label for Oralsoothe
View Indications, Usage & Precautions
Oralsoothe Product Label
The following document was submitted to the FDA by the labeler of this product Native Remedies, Llc. 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 & crying during teething
Otc - Active Ingredient
Active Ingredients: Each dose contains equal parts of: Calc fluor 8X HPUS, Calc phos 8X HPUS, Chamomilla 3X HPUS, Chamomilla 6C HPUS, Passiflora 3X HPUS.
Indications & Usage
Uses: Soothing homeopathic remedy for teething in babies and children.
Warnings
Warnings: If symptoms persist or worsen, consult a healthcare professional.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions: Babies:Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.
Inactive Ingredient
Inactive Ingredients: Citric acid, corn starch, potassium sorbate, sucrose.
Information For Patients
The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States.
All Native Remedies health products are specially 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
Contains no artificial flavors or artificial colors. No gluten added.
Package Label.Principal Display Panel
* Please review the disclaimer below.