FDA.reportPublic FDA data

Diarrhea

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:13:37

Label at a glance#

ProductDiarrhea
Active ingredientRANCID BEEF, ACONITUM NAPELLUS, SILVER NITRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COLLINSONIA CANADENSIS ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, ECBALLIUM ELATERIUM FRUIT, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, IRIS VERSICOLOR ROOT, LYCOPODIUM CLAVATUM SPORE, PODOPHYLLUM, GINGER, RADISH, TOBACCO LEAF, BILBERRY, HORSE CHESTNUT, ENGLISH WALNUT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) 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 Aesculus hipp. 6x, Juglans reg. 6x, Aconitum nap.15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Carbo veg. 15x, Chamomilla 15x, Cinchona 15x, Collinsonia 15x, Colocynthis 15x, Elaterium 15x, Gelsemium 15x, Ipecac. 15x, Iris versicolor 15x, Lycopodium 15x, Podoph. pelt. 15x, Raphanus 15x,Tabacum 15x, Vaccinium 15x, Zingiber 15x, Pyrogenum 30x.

OTC - PURPOSE SECTION

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

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
55714-2420-0Diarrhea15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2420-1Diarrhea30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2420-2Diarrhea50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2420DIARRHEA (PYROGENIUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CARBO VEG., CHAMOMILLA, CINCHONA, COLLINSONIA, COLOCYNTHIS, ELATERIUM, GELSEMIUM, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, PODOPH. PELT., RAPHANUS, TABACUM, VACCINIUM, ZINGIBER, AESCULUS HIPP., JUGLANS REGIA) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20201126_9148cd61-528e-3475-e053-2a95a90a1762.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-242055714-2420-1, 55714-2420-2, 55714-2420-0

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
ALCOHOL3K9958V90MIACT
RANCID BEEF29SUH5R3HUACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
ECBALLIUM ELATERIUM FRUIT8P8HWT6ZWCACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IPECAC62I3C8233LACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PODOPHYLLUM2S713A4VP3ACTIB
GINGERC5529G5JPQACTIB
RADISHEM5RP35463ACTIB
TOBACCO LEAF6YR2608RSUACTIB
BILBERRY9P2U39H18WACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
ENGLISH WALNUT1V3SHR7QB7ACTIB
WATER059QF0KO0RIACT

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
DiarrheaPYROGENIUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CARBO VEG., CHAMOMILLA, CINCHONA, COLLINSONIA, COLOCYNTHIS, ELATERIUM, GELSEMIUM, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, PODOPH. PELT., RAPHANUS, TABACUM, VACCINIUM, ZINGIBER, AESCULUS HIPP., JUGLANS REGIANewton Laboratories, Inc.9148cd61-528e-3475-e053-2a95a90a17622020-11-25WarningsExact identifier
ndc (package): 55714-2420-0
ndc (package): 55714-2420-2
ndc (package): 55714-2420-1
ndc (product): 55714-2420
ndc11 (package): 55714242001
ndc11 (package): 55714242000
ndc11 (package): 55714242002
spl id: b4f0a92e-e0c8-822a-e053-2995a90a4087
spl set id: 9148cd61-528e-3475-e053-2a95a90a1762

Reported adverse events (FAERS/openFDA)#

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