Digestive Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:09

Label at a glance#

ProductDigestive Care
Active ingredientAntimony Trisulfide, Silver Nitrate, Arsenic Trioxide, Baptisia Tinctoria Root, Bismuth, 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, Daikon, Toxicodendron Pubescens Leaf, Tobacco Leaf, Verbascum Thapsus, Ginger, Echinacea, Unspecified, Juglans Regia Fruit Rind, Immature
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Digestive Care  Formulated for digestive health and for symptoms associated with IBS, GERD, 'leaky gut' syndrome, dyspepsia and other GI conditions.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) 15 minutes before meals or as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

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, Echinacea 3x, Juglans regia 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for digestive health and for symptoms associated with IBS, GERD, 'leaky gut' syndrome, dyspepsia and other GI conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived pellets.

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.   

PREGNANCY OR BREAST FEEDING SECTION

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.

KEEP OUT OF REACH OF CHILDREN SECTION

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
55714-4511-12020-01-31C16284748780-19d75b9d1-0d3e-f424-e053-dadaa90a57ceDigestive Care
55714-4511-22020-01-31C16284748780-19d75b9d1-0d3e-f424-e053-dadaa90a57ceDigestive Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4511-1Digestive Care28.35 g in 1 BOTTLE, GLASSPELLET28.351
55714-4511-2Digestive Care56.7 g in 1 BOTTLE, GLASSPELLET56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4511DIGESTIVE 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) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20131105_4a9e0337-9cb2-0a38-4e3c-4fe7170129da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Baptisia Tinctoria RootACTIVE INGREDIENT5EF0HWI5WU1
BismuthACTIVE INGREDIENTU015TT5I8H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
DaikonACTIVE INGREDIENT86R5J6D01D1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
GingerACTIVE INGREDIENTC5529G5JPQ1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Juglans Regia Fruit Rind, ImmatureACTIVE INGREDIENTZPS7Q5U53K1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Magnesium CarbonateACTIVE INGREDIENT0E53J927NA1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
PodophyllumACTIVE INGREDIENT2S713A4VP31
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
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 Tinctoria RootACTIVE MOIETY5EF0HWI5WU1
BismuthACTIVE MOIETYU015TT5I8H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
DaikonACTIVE MOIETY86R5J6D01D1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
GingerACTIVE MOIETYC5529G5JPQ1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Juglans Regia Fruit Rind, ImmatureACTIVE MOIETYZPS7Q5U53K1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
PhosphorusACTIVE MOIETY27YLU75U4W1
PodophyllumACTIVE MOIETY2S713A4VP31
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Silver CationACTIVE MOIETY57N7B0K90A1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
SucroseINACTIVE INGREDIENTC151H8M5541

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
55714-451155714-4511-1, 55714-4511-2

Ingredients#

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

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

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 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
ab85aeec-7366-71e9-6472-2a6bd133d6074a9e0337-9cb2-0a38-4e3c-4fe7170129da2011-06-01WarningsExact identifier
spl id: ab85aeec-7366-71e9-6472-2a6bd133d607
spl set id: 4a9e0337-9cb2-0a38-4e3c-4fe7170129da

Reported adverse events (FAERS/openFDA)#

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