FDA.reportPublic FDA data

Diarrhea

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:34

Label at a glance#

ProductDiarrhea
Active ingredientSILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, CINCHONA OFFICINALIS BARK, COLLINSONIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, IRIS VERSICOLOR ROOT, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM CARBONATE, PHOSPHORUS, PODOPHYLLUM, RHEUM OFFICINALE ROOT, SULFUR, TOBACCO LEAF, BILBERRY, ECBALLIUM ELATERIUM FRUIT, JUGLANS REGIA LEAF, HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, VALERIAN, ACONITUM NAPELLUS
Label structure10 sections

Indications and uses

Formulated for associated symptoms such as loose or liquid stools, cramping, gas, nausea, irritation and fatigue.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as loose or liquid stools, cramping, gas, nausea, irritation and fatigue.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hippocastanum 6x, Juglans regia 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Carbo vegetabilis 15x, Chamomilla 15x, Cinchona officinalis 15x, Collinsonia canadensis 15x, Colocynthis 15x, Elaterium 15x, Gelsemium sempervirens 15x, Ipecacuanha 15x, Iris versicolor 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium myrtillus 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as loose or liquid stools, cramping, gas, nausea, irritation and fatigue.

INACTIVE INGREDIENT SECTION

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

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.

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
55714-1525-1Diarrhea30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1525DIARRHEA (AESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUS) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250129_9d7322da-c2fb-0fc3-e053-2a95a90ac70b.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-152555714-1525-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
WATER059QF0KO0RIACT
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IPECAC62I3C8233LACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
ALCOHOL3K9958V90MIACT
PHOSPHORUS27YLU75U4WACTIB
PODOPHYLLUM2S713A4VP3ACTIB
RHEUM OFFICINALE ROOTA47JP5ZG9MACTIB
SULFUR70FD1KFU70ACTIB
TOBACCO LEAF6YR2608RSUACTIB
BILBERRY9P2U39H18WACTIB
ECBALLIUM ELATERIUM FRUIT8P8HWT6ZWCACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
VALERIANJWF5YAW3QWACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB

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
DiarrheaAESCULUS HIPPOCASTANUM, JUGLANS REGIA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, ELATERIUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, RHEUM, SULPHUR, TABACUM, VACCINIUM MYRTILLUSNewton Laboratories, Inc.9d7322da-c2fb-0fc3-e053-2a95a90ac70b2025-01-27WarningsExact identifier
ndc (package): 55714-1525-1
ndc (product): 55714-1525
ndc11 (package): 55714152501
spl id: 2cb88746-192d-6d28-e063-6394a90aa046
spl set id: 9d7322da-c2fb-0fc3-e053-2a95a90ac70b

Reported adverse events (FAERS/openFDA)#

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