BOWEL - DIGESTIVE CARE - bismuth, antimony trisulfide, silver nitrate, arsenic trioxide, baptisia tinctoria, bryonia alba root, matricaria recutita, cinchona officinalis bark, iris versicolor root, potassium dichromate, lachesis muta venom, lycopodium clavatum spore, magnesium carbonate, strychnos nux-vomica seed, phosphorus, podophyllum, pulsatilla vulgaris, radish, toxicodendron pubescens leaf, tobacco leaf, verbascum thapsus, ginger, echinacea, unspecified and english walnut 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

Bowel - Digestive Care   Formulated for digestive health and for associated symptoms such as weak digestion, burning, bloating, nausea, cramping and pressure. 

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) 15 minutes before meals or 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

Bismuthum metallicum 15x, Antimon.crud. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Chamomilla 10x, Cinchona 10x, Iris versicolor 10x, Kali bic. 10x, Lachesis 10x, Lycopodium 10x, Mag. carb. 10x, Nux vom. 10x, Phosphorus 10x, Podoph. pelt. 10x, Pulsatilla 10x, Raphanus 10x, Rhus toxicodendron 10x, Tabacum 10x, Verbascum 10x, Zingiber 10x, Echinacea 3x, Juglans regia 3x.

OTC - PURPOSE SECTION

 Formulated for digestive health and for associated symptoms such as weak digestion, burning, bloating, nausea, cramping and pressure.

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 la

BOWEL - DIGESTIVE CARE  
bismuthum metallicum, antimon.crud., arg. nit., arsenicum alb., baptisia, bryonia, chamomilla, cinchona, iris versicolor, kali bic., lachesis, lycopodium, mag. carb., nux vom., phosphorus, podoph. pelt., pulsatilla, raphanus, rhus toxicodendron, tabacum, verbascum, zingiber, echinacea, juglans regia. liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2256
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth (Bismuth) Bismuth15 [hp_X]  in 1 mL
Antimony Trisulfide (Antimony Trisulfide) Antimony Trisulfide10 [hp_X]  in 1 mL
Silver Nitrate (Silver Cation) Silver Nitrate10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Baptisia Tinctoria (Baptisia Tinctoria) Baptisia Tinctoria10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Matricaria Recutita (Matricaria Recutita) Matricaria Recutita10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Iris Versicolor Root (Iris Versicolor Root) Iris Versicolor Root10 [hp_X]  in 1 mL
Potassium Dichromate (Dichromate Ion) Potassium Dichromate10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Magnesium Carbonate (Carbonate Ion) Magnesium Carbonate10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_M]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Podophyllum (Podophyllum) Podophyllum10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Radish (Radish) Radish10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Tobacco Leaf (Tobacco Leaf) Tobacco Leaf10 [hp_X]  in 1 mL
Verbascum Thapsus (Verbascum Thapsus) Verbascum Thapsus10 [hp_X]  in 1 mL
Ginger (Ginger) Ginger10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
English Walnut (English Walnut) English Walnut3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2256-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2256-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2256-0.5 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(55714-2256), API MANUFACTURE(55714-2256)

Revised: 03/2011
Document Id: a010404f-4d9a-9e6a-292a-4924f7c228f0
Set id: 09bbe0ad-129c-48fc-2810-df190f2fe6e6
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.