Otc - Purpose
Relieves ear aches in babies and children
Eddy Ear Sprinkles
FDA Label NDC 68647-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Feelgood Health for the product Eddy Ear Sprinkles (NDC 68647-161). 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 - purpose, indications & usage, dosage & administration, general precautions, otc - active ingredient, inactive ingredient, pregnancy, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Indications: Homeopathic remedy for ear ache in children.
Dosage & Administration
Dosage: 1 pinch onto the tongue hourly for 6-10 doses. Thereafter 3 times daily for 5-7 days. Use with Ear OK Drops™ for combined support.
General Precautions
Caution: If symptoms persist or worsen, a health care professional should be consulted.
Otc - Active Ingredient
Ingredients: Each dose contains equal parts of Echinacea purp (3X) (HPUS), Chamomilla (3X) (HPUS), Calc sulph (6X) (HPUS), Ferrum phos (6X) (HPUS), Pulsatilla (12C) (HPUS), Belladonna (30C) (HPUS)
Inactive Ingredient
Sucrose (inactive ingredient).
Pregnancy
If pregnant or breastfeeding, ask a health professional before use.
Warnings
Contains no gluten, artificial flavors, colors or preservatives. Safe for all ages and during pregnancy.
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 (Eddyearsprinkles)
Otc - Keep Out Of Reach Of Children
Keep this and all medicines from the reach of children.
* Please review the disclaimer below.
