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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

Capsicum Annuum 6X, Silicea 6X, Verbascum Thapsus 6X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Aconitum Napellus 30X, Belladonna 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.

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

NDC 64471-263-48

with

PainSoothe

Homeopathic Belladonna & Mullein

Children's Formula

Wellness

EarAche

Pain • Blockage • Inflammation • Irritability • Fever

48 HOMEOPATHIC TABLETS

Wellness EarAche ctn front

Wellness EarAche ctn back

WELLNESS EARACHE 
capsicum annuum, silicea, verbascum thapsus, ferrum phosphoricum, kali muriaticum, aconitum napellus, belladonna, calcarea carbonica, pulsatilla (pratensis) tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64471-263
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS6 [hp_X]
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM12 [hp_X]
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION12 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS30 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (TABLET) Size10mm
FlavorgrapeImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64471-263-482 in 1 CARTON11/17/201611/30/2022
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/17/201611/30/2022
Labeler - Source Naturals, Inc. (969024228)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(64471-263) , api manufacture(64471-263) , label(64471-263) , pack(64471-263)

Revised: 11/2022
 
Source Naturals, Inc.