Diarrhea

Diarrhea
SPL v1
SPL
SPL Set ID 32543f0f-a40b-bf42-86e4-e20a67a621c7
Route
ORAL
Published
Effective Date 2012-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Silver Cation (3 [hp_X]) Arsenic Cation (3+) Baptisia Tinctoria Bryonia Alba Root Activated Charcoal Matricaria Recutita Cinchona Officinalis Bark Collinsonia Canadensis Root Citrullus Colocynthis Fruit Pulp Ecballium Elaterium Fruit Gelsemium Sempervirens Root Ipecac Iris Versicolor Root Lycopodium Clavatum Spore Carbonate Ion Phosphorus Podophyllum Rheum Officinale Whole Sulfur Tobacco Leaf Bilberry Horse Chestnut Juglans Regia Whole Valerian
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Diarrhea  Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Purpose

Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.


Medication Information

Purpose

Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Description

Diarrhea  Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Inactive Ingredient Section

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

Indications & Usage Section

Diarrhea  Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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

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 versicolor 15x, Lycopodium 15x, Mag. carb. 15x, Phosphorus 15x, Podoph. pelt. 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium 15x, Aesculus hipp. 3x, Juglans regia 3x, Valeriana 3x.

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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Diarrhea  Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 (OTC - ACTIVE INGREDIENT SECTION)

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 versicolor 15x, Lycopodium 15x, Mag. carb. 15x, Phosphorus 15x, Podoph. pelt. 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium 15x, Aesculus hipp. 3x, Juglans regia 3x, Valeriana 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)