Constipation

Constipation
SPL v1
SPL
SPL Set ID 94a0263f-ea1d-bd46-4fe8-d02ad0aa062c
Route
ORAL
Published
Effective Date 2012-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Picea Mariana Resin (15 [hp_X]) Horse Chestnut (3 [hp_X]) Aloe Aluminum Oxide Bryonia Alba Root Activated Charcoal Chelidonium Majus Collinsonia Canadensis Root Graphite Goldenseal Carbonate Ion Lycopodium Clavatum Spore Magnesium Cation Daphne Mezereum Bark Strychnos Nux-vomica Seed Podophyllum Frangula Purshiana Bark Sanicula Europaea Leaf Selenium Sepia Officinalis Juice Silicon Dioxide Tobacco Leaf Veratrum Album Root Zinc Echinacea, Unspecified Iris Versicolor Root Phytolacca Americana Root Taraxacum Officinale
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01
Description

Constipation  Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Purpose

Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Medication Information

Purpose

Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Description

Constipation  Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

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 difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Inactive Ingredient Section

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

Indications & Usage Section

Constipation  Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 15x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 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 difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Constipation  Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Abies nig. 15x, Aesculus hipp. 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo veg. 15x, Chelidonium majus 15x, Collinsonia 15x, Graphites 15x, Hydrastis 15x, Kali carb. 15x, Lycopodium 15x, Mag. mur. 15x, Mezereum 15x, Nux vom. 15x, Podoph. pelt. 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum alb. 15x, Zinc.met. 15x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:15.405909 · Updated: 2026-03-14T23:14:27.680965