EARACHE KIDS RELIEF - ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid 
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 (Ferrosoferric phosphate) 30X

Capsicum annuum (Cayenne pepper) 30X

Pyrogenium (Pyrogen) 30X

Arsenicum album (Arsenous oxide) 30X

Belladonna (Deadly nightshade) 30X

PURPOSE

Inflammation and fever.

Acute pain and pressure in the ears.

Infection and fever.

Burning pain in the ears.

Throbbing pain and inflammation.

This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

USES

This homeopathic medicine helps relieve symptoms associated with earaches:

- throbbing pain

- inflammation

- pressure in ears

- fever

WARNINGS


Do not use if seal is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Do not take with food.

Take .75 ml orally.

Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.


Infants and children 0 to 9 years of age: .75 ml

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

image of carton label

LABEL

image of bottle label

EARACHE KIDS RELIEF 
ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9063
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM30 [hp_X]  in 25 mL
RED PEPPER (UNII: 6M47G7C4SY) (RED PEPPER - UNII:6M47G7C4SY) RED PEPPER30 [hp_X]  in 25 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 25 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE30 [hp_X]  in 25 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 25 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE, RASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9063-81 in 1 CARTON
125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/2008
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture

Revised: 5/2010
Document Id: 15df66c3-bb76-467a-a732-5fc39b46c47e
Set id: 488b2924-12cc-4c26-a51f-69990b397015
Version: 1
Effective Time: 20100531
 
HOMEOLAB USA INC