Constipation 2413p

Constipation 2413p
SPL v2
SPL
SPL Set ID 90804a94-1e67-3ab3-e053-2a95a90aafbe
Route
ORAL
Published
Effective Date 2019-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Picea Mariana Resin (15 [hp_X]) Horse Chestnut (6 [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 2019-01-31

Description

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Purpose

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.


Medication Information

Purpose

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Description

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health 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

Equal parts of Echinacea 6x, Iris vers. 6x, Phytolacca 6x, Taraxacum 6x, 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.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as difficult elimination, hard stools, pain, cramping, itching and bloating.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health 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)

Equal parts of Echinacea 6x, Iris vers. 6x, Phytolacca 6x, Taraxacum 6x, 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.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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

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