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Ear Care

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Ear Care


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

EAR CARE     Formulated for symptoms associated with Meniere's disease, mastoiditis, otitis, otorrhea and other related ear conditions.   

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets ) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

Influenzinum 30x, Tellurium metallicum 15x, Apis mel. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Capsicum 10x, Causticum 10x, Cinchona 10x, Conium 10x, Dulcamara 10x, Ferrum phosphoricum 10x, Hepar sulph. calc. 10x, Kali sulph. 10x, Lycopodium 10x, Merc. viv. 10x, Mezereum 10x, Phosphorus 10x, Plantago 10x, Pulsatilla 10x, Silicea 10x, Verbascum 10x, Echinacea 3x, Hydrastis 3x.           

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.         

QUESTIONS? SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256   

WARNINGS SECTION

Warning: Do not use if tamper- evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.              

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days      

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.          

PACKAGE LABEL

Ear Care

Influenzinum, Tellurium metallicum, Apis mel, Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc., Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis PELLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4417
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS Influenza A Virus 30 [hp_X]
Tellurium Tellurium 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 10 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
Capsicum CAPSICUM 10 [hp_X]
CAUSTICUM CAUSTICUM 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 10 [hp_X]
SOLANUM DULCAMARA STEM SOLANUM DULCAMARA STEM 10 [hp_X]
FERROSOFERRIC PHOSPHATE Ferrosoferric Phosphate 10 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 10 [hp_X]
potassium sulfate 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
MERCURY Mercury 10 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 10 [hp_X]
PHOSPHORUS PHOSPHORUS 10 [hp_X]
PLANTAGO MAJOR PLANTAGO MAJOR 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
SILICON DIOXIDE 10 [hp_X]
VERBASCUM THAPSUS VERBASCUM THAPSUS 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
GOLDENSEAL GOLDENSEAL 3 [hp_X]
INFLUENZA B VIRUS Influenza B Virus 30 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4417-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-4417-2 56.7 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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