FDA.reportPublic FDA data

Bowel-Digestive Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:39

Label at a glance#

ProductBowel-Digestive Care
Active ingredientGINGER, ECHINACEA, UNSPECIFIED, ARSENIC TRIOXIDE, ANTIMONY TRISULFIDE, SILVER NITRATE, BISMUTH, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, CINCHONA OFFICINALIS BARK, IRIS VERSICOLOR ROOT, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, PODOPHYLLUM, ANEMONE PULSATILLA, RADISH, TOBACCO LEAF, BAPTISIA TINCTORIA ROOT, JUGLANS REGIA LEAF, VERBASCUM THAPSUS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) 15 minutes before meals, as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Juglans regia 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Chamomilla 15x, Cinchona officinalis 15x, Iris versicolor 15x, Kali bichromicum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Nux vomica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Raphanus sativus 15x, Rhus toxicodendron 15x, Tabacum 15x, Verbascum thapsus15x, Zingiber officinale 15x

OTC - PURPOSE SECTION

Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: 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.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1534-1Bowel-Digestive Care30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1534BOWEL-DIGESTIVE CARE (ECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALE) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250130_9d60d399-6f63-5842-e053-2995a90a7cf7.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-153455714-1534-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GINGERC5529G5JPQACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER NITRATE95IT3W8JZEACTIB
WATER059QF0KO0RIACT
BISMUTHU015TT5I8HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ALCOHOL3K9958V90MIACT
PHOSPHORUS27YLU75U4WACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
PODOPHYLLUM2S713A4VP3ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
RADISHEM5RP35463ACTIB
TOBACCO LEAF6YR2608RSUACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB

Source Document#

Source XML

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
Bowel-Digestive CareECHINACEA, JUGLANS REGIA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CHAMOMILLA, CINCHONA OFFICINALIS, IRIS VERSICOLOR, KALI BICHROMICUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RAPHANUS SATIVUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM THAPSUS, ZINGIBER OFFICINALENewton Laboratories, Inc.9d60d399-6f63-5842-e053-2995a90a7cf72025-01-28WarningsExact identifier
ndc (package): 55714-1534-1
ndc (product): 55714-1534
ndc11 (package): 55714153401
spl id: 2cc85881-a8bd-15f4-e063-6394a90a88a1
spl set id: 9d60d399-6f63-5842-e053-2995a90a7cf7

Reported adverse events (FAERS/openFDA)#

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