WELLNESS EARACHE (capsicum annuum, silicea, verbascum thapsus, ferrum phosphoricum, kali muriaticum, aconitum napellus, belladonna, calcarea carbonica, pulsatilla- pratensis tablet, chewable

Wellness Earache by

Drug Labeling and Warnings

Wellness Earache by is a Homeopathic medication manufactured, distributed, or labeled by Source Naturals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Capsicum Annuum 6X, Silicea 6X, Verbascum Thapsus 6X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Aconitum Napellus 30X, Calcarea Carbonica 30X, Pulsatilla (Pratensis) 30X.

INDICATIONS:

For the temporary relief of ear pain, blockage, ear inflammation, irritability and fever associated with earaches.

WARNINGS:

In case of overdose, get medical help or contact a Poison Control Center right away.

A high fever may be the sign of a serious health condition. If fever or ear pain persist for more than 2 days or new symptoms occur, consult a physician.

As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a physician before using this product.

Keep this and all medicines out of the reach of children.

Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number.

Contains Milk.

KEEP OUT OF REACH OF CHILDREN:

Keep this and all medicines out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Chew 1 tablet slightly and let it dissolve in the mouth or under the tongue. For infants, crush a tablet between two spoons, add water or juice if desired, and place in mouth. Repeat every 2 to 4 hours as needed, for up to 48 hours. For optimal results take 3-4 doses per day.

One or two doses per day may be taken for up to 4 weeks if symptoms recur or do not resolve completely.

Give Wellness EarAche to children or infants over 6 months of age. This product is not recommended for use by infants under 6 months of age without the advice of your physician.

For Best Results: Keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. These substances may interfere with sublingual absorption.

INDICATIONS:

For the temporary relief of ear pain, blockage, ear inflammation, irritability and fever associated with earaches.

INACTIVE INGREDIENTS:

Lactose and Magnesium Stearate.

QUESTIONS:

Source Naturals, Inc.
P.O. Box 2118
Santa Cruz, CA. USA 95062
www.sourcenaturals.com

PACKAGE LABEL DISPLAY:

SOURCE NATURALS

with

PainSoothe

Homeopathic

Children's

Formula

Wellness

EarAche

Pain Blockage Inflammation Irritability Fever

48 HOMEOPATHIC TABLETS

INGREDIENTS AND APPEARANCE

WELLNESS EARACHE 
capsicum annuum, silicea, verbascum thapsus, ferrum phosphoricum, kali muriaticum, aconitum napellus, belladonna, calcarea carbonica, pulsatilla (pratensis) tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64471-126
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 [hp_X]
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	6 [hp_X]
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X]
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	12 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_X]
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI)	PULSATILLA PRATENSIS	30 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64471-126-48	2 in 1 CARTON	06/13/2018
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/13/2018

Labeler - Source Naturals, Inc. (969024228)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(64471-126) , api manufacture(64471-126) , label(64471-126) , pack(64471-126)