FDA.reportPublic FDA data

Digestive Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:04:34

Label at a glance#

ProductDigestive Care
Active ingredientBISMUTH, ANTIMONY TRISULFIDE, SILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, 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 pellets by mouth (ages 0 to 11, give 3 pellets) 15 minutes before meals or as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Juglans reg. 6x, Antimon.crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuth. met. 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 cramping, alternating constipation & diarrhea, indigestion, bloating and heartburn.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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 then 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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4755DIGESTIVE 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.) PELLET [NEWTON LABORATORIES, INC.]2Legacy NDC20201203_98f8e073-342c-0678-e053-2a95a90aa2e2.zip

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
55714-475555714-4755-1

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
SUCROSEC151H8M554IACT
BISMUTHU015TT5I8HACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
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
4965eb5f-6bbd-03fe-e063-6294a90a781898f8e073-342c-0678-e053-2a95a90aa2e22026-01-27WarningsExact identifier
spl set id: 98f8e073-342c-0678-e053-2a95a90aa2e2

Reported adverse events (FAERS/openFDA)#

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