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Diarrhea

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Diarrhea


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Diarrhea  Formulated for symptoms of intestinal upset such as loose or liquid stools, intestinal cramping, nausea, flatulence and fatigue. 

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Pyrogenium 30x, Aconitum nap.15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Carbo veg. 15x, Chamomilla 15x, Cinchona 15x, Collinsonia 15x, Colocynthis 15x, Elaterium 15x, Gelsemium 15x, Ipecac. 15x, Iris vers. 15x, Lycopodium 15x, Podoph. pelt. 15x, Raphanus 15x,Tabacum 15x, Vaccinium 15x, Zingiber 15x, Aesculus hipp. 3x, Juglans reg. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms of intestinal upset such as loose or liquid stools, intestinal cramping, nausea, flatulence and fatigue.

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.

OTC - 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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Diarrhea

Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-8014
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RANCID BEEF RANCID BEEF 30 [hp_X]
ACONITUM NAPELLUS ACONITUM NAPELLUS 15 [hp_X]
SILVER NITRATE SILVER CATION 15 [hp_X]
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 15 [hp_X]
Baptisia Tinctoria Baptisia Tinctoria 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
Activated Charcoal ACTIVATED CHARCOAL 15 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 15 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 15 [hp_X]
COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT 15 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP 15 [hp_X]
Ecballium Elaterium Fruit ECBALLIUM ELATERIUM FRUIT 15 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]
Ipecac IPECAC 15 [hp_X]
Iris Versicolor Root Iris Versicolor Root 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
Podophyllum Podophyllum 15 [hp_X]
RADISH Radish 15 [hp_X]
TOBACCO LEAF TOBACCO LEAF 15 [hp_X]
BILBERRY Bilberry 15 [hp_X]
GINGER 15 [hp_X]
HORSE CHESTNUT HORSE CHESTNUT 3 [hp_X]
ENGLISH WALNUT English Walnut 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-8014-1 29.57 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2014-04-15


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