CONSTIPATION - picea mariana resin, horse chestnut, aloe, aluminum oxide, bryonia alba root, activated charcoal, chelidonium majus, collinsonia canadensis root, graphite, goldenseal, potassium carbonate, lycopodium clavatum spore, magnesium chloride, 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 and taraxacum officinale liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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: ORAL USE ONLY - SHAKE WELL.  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

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: 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

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 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2214
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Picea Mariana Resin (Picea Mariana Resin) Picea Mariana Resin15 [hp_X]  in 1 mL
Horse Chestnut (Horse Chestnut) Horse Chestnut15 [hp_X]  in 1 mL
Aloe (Aloe) Aloe15 [hp_X]  in 1 mL
Aluminum Oxide (Aluminum Oxide) Aluminum Oxide15 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root15 [hp_X]  in 1 mL
Activated Charcoal (Activated Charcoal) Activated Charcoal15 [hp_X]  in 1 mL
Chelidonium Majus (Chelidonium Majus) Chelidonium Majus15 [hp_X]  in 1 mL
Collinsonia Canadensis Root (Collinsonia Canadensis Root) Collinsonia Canadensis Root15 [hp_X]  in 1 mL
Graphite (Graphite) Graphite15 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal15 [hp_X]  in 1 mL
Potassium Carbonate (Carbonate Ion) Potassium Carbonate15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Magnesium Chloride (Magnesium Cation) Magnesium Chloride15 [hp_X]  in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Podophyllum (Podophyllum) Podophyllum15 [hp_X]  in 1 mL
Frangula Purshiana Bark (Frangula Purshiana Bark) Frangula Purshiana Bark15 [hp_X]  in 1 mL
Sanicula Europaea Leaf (Sanicula Europaea Leaf) Sanicula Europaea Leaf15 [hp_X]  in 1 mL
Selenium (Selenium) Selenium15 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Silicon Dioxide (Silicon Dioxide) Silicon Dioxide15 [hp_X]  in 1 mL
Tobacco Leaf (Tobacco Leaf) Tobacco Leaf15 [hp_X]  in 1 mL
Veratrum Album Root (Veratrum Album Root) Veratrum Album Root15 [hp_X]  in 1 mL
Zinc (Zinc) Zinc15 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Iris Versicolor Root (Iris Versicolor Root) Iris Versicolor Root3 [hp_X]  in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root) Phytolacca Americana Root3 [hp_X]  in 1 mL
Taraxacum Officinale (Taraxacum Officinale) Taraxacum Officinale3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2214-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2214-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2214-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2214), API MANUFACTURE(55714-2214)

Revised: 03/2011
Document Id: b48c0baa-7070-6443-6325-1456fdcfc9e7
Set id: 86072a44-317a-bbfe-705f-af5bfe082893
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.