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Tinnitus

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Tinnitus


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Tinnitus    Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x, Hydrastis 8x, Hydrastis 3x.

PURPOSE SECTION

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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.

PREGNANCY OR BREAST FEEDING SECTION

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

Tinnitus

Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55714-4584
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 15 [hp_X]
BARIUM CARBONATE BARIUM CATION 15 [hp_X]
Barium Chloride Dihydrate BARIUM CATION 15 [hp_X]
Capsicum CAPSICUM 15 [hp_X]
CAUSTICUM CAUSTICUM 15 [hp_X]
Dysphania Ambrosioides CHENOPODIUM AMBROSIOIDES 15 [hp_X]
Quinine Sulfate QUININE 15 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 15 [hp_X]
nitroglycerin NITROGLYCERIN 15 [hp_X]
Graphite GRAPHITE 15 [hp_X]
GOLDENSEAL GOLDENSEAL 15 [hp_X]
POTASSIUM DICHROMATE DICHROMATE ION 15 [hp_X]
potassium chloride 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
PHOSPHORUS PHOSPHORUS 15 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 15 [hp_X]
Salicylic Acid SALICYLIC ACID 15 [hp_X]
TOBACCO LEAF TOBACCO LEAF 15 [hp_X]
Allylthiourea ALLYLTHIOUREA 15 [hp_X]
VIOLA ODORATA VIOLA ODORATA 15 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4584-1 29.57 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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