Constipation description, usages, side effects, indications, overdosage, supplying and lots more!

Constipation

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Constipation

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 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 - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

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

Constipation

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2215
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PICEA MARIANA RESIN PICEA MARIANA RESIN 15 [hp_X]
HORSE CHESTNUT HORSE CHESTNUT 15 [hp_X]
ALOE ALOE 15 [hp_X]
ALUMINUM OXIDE 15 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 15 [hp_X]
Activated Charcoal ACTIVATED CHARCOAL 15 [hp_X]
CHELIDONIUM MAJUS CHELIDONIUM MAJUS 15 [hp_X]
COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT 15 [hp_X]
Graphite GRAPHITE 15 [hp_X]
GOLDENSEAL GOLDENSEAL 15 [hp_X]
POTASSIUM CARBONATE CARBONATE ION 15 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 15 [hp_X]
MAGNESIUM CHLORIDE 15 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 15 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 15 [hp_X]
Podophyllum Podophyllum 15 [hp_X]
FRANGULA PURSHIANA BARK FRANGULA PURSHIANA BARK 15 [hp_X]
Sanicula Europaea Leaf Sanicula Europaea Leaf 15 [hp_X]
Selenium SELENIUM 15 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 15 [hp_X]
SILICON DIOXIDE 15 [hp_X]
TOBACCO LEAF TOBACCO LEAF 15 [hp_X]
VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT 15 [hp_X]
Zinc ZINC 15 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
Iris Versicolor Root Iris Versicolor Root 3 [hp_X]
PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2215-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-2215-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-2215-0 7.08 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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