EARACHE KIDS RELIEF: Homeopathic Product Information

EARACHE KIDS RELIEF- ferrum phosphoricum, red pepper, rancid beef, arsenic trioxide and atropa belladonna liquid
CVS PHARMACY

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.

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 imprinted shrink seal neckband 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 0.75 ml orally.

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

Infants and children up to 9 years of age: 0.75 ml

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

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

CARTON

EARACHE KIDS RELIEF ferrum phosphoricum, capsicum annuum, pyrogenium, arsenicum album, belladonna liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-208 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 30 [hp_X] in 25 mL RED PEPPER (RED PEPPER) RED PEPPER 30 [hp_X] in 25 mL RANCID BEEF (RANCID BEEF) RANCID BEEF 30 [hp_X] in 25 mL ARSENIC TRIOXIDE (ARSENIC CATION (3)) ARSENIC TRIOXIDE 30 [hp_X] in 25 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 30 [hp_X] in 25 mL

Inactive Ingredients Ingredient Name Strength WATER SORBITOL SODIUM BENZOATE POTASSIUM SORBATE CITRIC ACID MONOHYDRATE

Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59779-208-02 25 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/07/2012

Labeler — CVS PHARMACY (062312574)

Registrant — HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Operations
HOMEOLAB USA INC		202032533	manufacture (59779-208)

Revised: 12/2012 CVS PHARMACY