FDA.reportPublic FDA data

Digestive Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:35:30

Label at a glance#

ProductDigestive Care
Active ingredientBISMUTH, ANTIMONY TRISULFIDE, SILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, 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, PODOPHYLLUM, ANEMONE PULSATILLA, RADISH, TOXICODENDRON PUBESCENS LEAF, TOBACCO LEAF, VERBASCUM THAPSUS, GINGER, ECHINACEA, UNSPECIFIED, JUGLANS REGIA LEAF
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) 15 minutes before meals or as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Juglans reg 11x, Antimon crud 20x, Arg nit 20x, Arsenicum alb 20x, Baptisia 20x, Bismuth met 20x, Bryonia 20x, Chamomilla 20x, Cinchona 20x, Iris vers 20x, Kali bic 20x, Lachesis 20x, Lycopodium 20x, Mag carb 20x, Nux vom 20x, Phos 20x, Podoph pelt 20x, Pulsatilla 20x, Raphanus 20x, Rhus tox 20x, Tabacum 20x, Verbascum 20x, Zingiber 20x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as crampting, alternating constipation & diarrhea, indigestion, bloating and heartburn.

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
55714-4860-1Digestive Care30 mL in 1 BOTTLE, GLASSLIQUID301

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
55714-486055714-4860-1

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BISMUTHU015TT5I8HACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
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
PHOSPHORUS27YLU75U4WACTIB
PODOPHYLLUM2S713A4VP3ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
RADISHEM5RP35463ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
TOBACCO LEAF6YR2608RSUACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
GINGERC5529G5JPQACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB

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
Digestive CareBISMUTHUM 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.Newton Laboratories, Inc.44e7e28b-88e5-784b-e063-6294a90a60022025-12-01WarningsExact identifier
ndc (package): 55714-4860-1
ndc (product): 55714-4860
ndc11 (package): 55714486001
spl id: 44e7e4d2-c018-8b16-e063-6294a90a3519
spl set id: 44e7e28b-88e5-784b-e063-6294a90a6002

Reported adverse events (FAERS/openFDA)#

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