FDA.reportPublic FDA data

Bowel - Digestive Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:41

Label at a glance#

ProductBowel - Digestive Care
Active ingredientBismuth, 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, English Walnut
Label structure10 sections

Label contents#

Full prescribing information#

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 -  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 met. 15x, Antimon.crud. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Chamomilla 10x, Cinchona 10x, Iris vers. 10x, Kali bic. 10x, Lachesis 10x, Lycopodium 10x, Mag. carb. 10x, Nux vom. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Raphanus 10x, Rhus tox. 10x, Tabacum 10x, Verbascum 10x, Zingiber 10x, Echinacea 3x, Juglans reg. 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

OTC - 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.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-8005-12020-01-31C16284748780-19d75b9d1-2aa5-f424-e053-dadaa90a57ceBowel - Digestive Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8005-1Bowel - Digestive Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8005BOWEL - 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 [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20140429_efdbeb28-a2d1-f869-28e9-80add7622393.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y1
BismuthACTIVE INGREDIENTU015TT5I8H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
English WalnutACTIVE INGREDIENT1V3SHR7QB71
GingerACTIVE INGREDIENTC5529G5JPQ1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Magnesium CarbonateACTIVE INGREDIENT0E53J927NA1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
PodophyllumACTIVE INGREDIENT2S713A4VP31
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
RadishACTIVE INGREDIENTEM5RP354631
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Antimony TrisulfideACTIVE MOIETYF79059A38U1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y1
BismuthACTIVE MOIETYU015TT5I8H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
English WalnutACTIVE MOIETY1V3SHR7QB71
GingerACTIVE MOIETYC5529G5JPQ1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
PhosphorusACTIVE MOIETY27YLU75U4W1
PodophyllumACTIVE MOIETY2S713A4VP31
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
RadishACTIVE MOIETYEM5RP354631
Silver CationACTIVE MOIETY57N7B0K90A1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-800555714-8005-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
BismuthU015TT5I8HACTIB
Antimony TrisulfideF79059A38UACTIB
Silver Nitrate95IT3W8JZEACTIB
Arsenic TrioxideS7V92P67HOACTIM
Baptisia Tinctoria5K1UO2888YACTIB
Bryonia Alba RootT7J046YI2BACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Potassium DichromateT4423S18FMACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Magnesium Carbonate0E53J927NAACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Podophyllum2S713A4VP3ACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
RadishEM5RP35463ACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Tobacco Leaf6YR2608RSUACTIB
Verbascum ThapsusC9TD27U172ACTIB
GingerC5529G5JPQACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
English Walnut1V3SHR7QB7ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6875ba7a-d7cf-80d6-5be0-a250351a7211efdbeb28-a2d1-f869-28e9-80add76223932014-04-15WarningsExact identifier
spl id: 6875ba7a-d7cf-80d6-5be0-a250351a7211
spl set id: efdbeb28-a2d1-f869-28e9-80add7622393

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.