EARACHE RELIEF- ferrum phosphoricum, capsicum annuum, thuja occidentalis, silicea, mercurius vivus, kali phosphoricum, pyrogenium pellet 
HOMEOLAB USA 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 HPUS

Ferrum phosphoricum 8X

Capsicum annuum 5X

Thuja occidentalis 5X

Silicea 8X

Mercurius vivus 8X

Kali phosphoricum 6X

Pyrogenium 12X

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

PURPOSE

Earache Pain

USES

This is a natural Homeopathic remedy that helps relieve earache pain.

WARNINGS

If symptoms persist or worsen, discontinue use and contact a health professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep this and all medications out of reach of children.

DIRECTIONS

Adults: Allow 3 to 4 pellets to dissolve in mouth three times a day. 

Children under 12: Take 1/2 the adult dose. Do not exceed recommended dosage.

OTHER INFORMATION

Do not use if cap seal is broken.

Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

PRODUCT OF CANADA

INACTIVE INGREDIENTS

Lactose, sucrose

CARTON

IMAGE OF CARTONIMAGE OF LABEL

EARACHE RELIEF 
ferrum phosphoricum, capsicum annuum, thuja occidentalis, silicea, mercurius vivus, kali phosphoricum, pyrogenium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-2020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE5 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG5 [hp_X]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY8 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-2020-180 in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/18/2013
Labeler - HOMEOLAB USA INC. (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC.202032533manufacture(60512-2020)

Revised: 11/2013
Document Id: c0535023-d30d-46a4-bc3a-543234984dce
Set id: d2b35877-c410-4ecb-8b4e-54b639824d17
Version: 2
Effective Time: 20131105
 
HOMEOLAB USA INC.