BOWEL - DIGESTIVE CARE- antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, 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 
Newton Laboratories, Inc.

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.

----------

Bowel - Digestive Care

INDICATIONS & USAGE SECTION

Bowel - Digestive Care     Formulated for associated  symptoms such as loose stools, constipation, flatulence, vomiting and poor appetite.

DOSAGE & ADMINISTRATION SECTION

  Pets, under 50 lbs., give 3 drops by mouth  (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) as needed or as directed by a health professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of  Echinacea 6x, Juglans regia 6x, Antimon. crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuthum metallicum 15x, Bryonia 15x, Chamomilla 15x, Cinchona 15x, Iris versicolor 15x, Kali bic. 15x, Lachesis 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Raphanus 15x, Rhus toxicodendron 15x, Tabacum 15x, Verbascum 15x, Zingiber 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as loose stools, constipation, flatulence, vomiting and poor appetite.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.  

QUESTIONS SECTION

newtonlabs.net -  Questions?  1.800.448.7256  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

Warning: 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.   

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.

PACKAGE LABEL

package label
Product label

BOWEL - DIGESTIVE CARE 
antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, 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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4279
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria15 [hp_X]  in 1 mL
Bismuth (UNII: U015TT5I8H) (Bismuth - UNII:U015TT5I8H) Bismuth15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 mL
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate15 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D) Magnesium Carbonate15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum15 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
Radish (UNII: EM5RP35463) (Radish - UNII:EM5RP35463) Radish15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [hp_X]  in 1 mL
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
Juglans Regia Leaf (UNII: 85HKB87105) (Juglans Regia Leaf - UNII:85HKB87105) Juglans Regia Leaf3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4279-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4279-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-4279-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201112/31/2018
BOWEL - DIGESTIVE CARE 
antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, 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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4276
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria15 [hp_X]  in 1 mL
Bismuth (UNII: U015TT5I8H) (Bismuth - UNII:U015TT5I8H) Bismuth15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root15 [hp_X]  in 1 mL
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate15 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D) Magnesium Carbonate15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum15 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
Radish (UNII: EM5RP35463) (Radish - UNII:EM5RP35463) Radish15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [hp_X]  in 1 mL
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus15 [hp_X]  in 1 mL
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified6 [hp_X]  in 1 mL
Juglans Regia Leaf (UNII: 85HKB87105) (Juglans Regia Leaf - UNII:85HKB87105) Juglans Regia Leaf6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4276-130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/14/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE

Revised: 1/2019
Document Id: 10846871-c135-4183-b840-6d8e2a05762f
Set id: 539890e4-6361-7bef-ec59-cb620416c822
Version: 2
Effective Time: 20190114
 
Newton Laboratories, Inc.