FDA.reportPublic FDA data

Diarrhea

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:40

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, Radish, Tobacco Leaf, Bilberry, Ginger, Horse Chestnut, English Walnut
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Pyrogenium 30x, 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 vers. 15x, Lycopodium 15x, Podoph. pelt. 15x, Raphanus 15x,Tabacum 15x, Vaccinium 15x, Zingiber 15x, Aesculus hipp. 3x, Juglans reg. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms of intestinal upset 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 dispensing alcohol 20%.  

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.

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. 

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
55714-8014-12020-01-31C16284748780-19d75b9d0-ff82-f424-e053-dadaa90a57ceDiarrhea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8014-1Diarrhea29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8014DIARRHEA (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.]1Legacy NDC, 1 package rows20140429_c0d1d114-7e8c-b7ed-f421-ba8d3c305a9e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Activated CharcoalACTIVE INGREDIENT2P3VWU3H101
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y1
BilberryACTIVE INGREDIENT9P2U39H18W1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Citrullus Colocynthis Fruit PulpACTIVE INGREDIENT23H32AOH171
Collinsonia Canadensis RootACTIVE INGREDIENTO2630F3XDR1
Ecballium Elaterium FruitACTIVE INGREDIENT8P8HWT6ZWC1
English WalnutACTIVE INGREDIENT1V3SHR7QB71
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GingerACTIVE INGREDIENTC5529G5JPQ1
Horse ChestnutACTIVE INGREDIENT3C18L6RJAZ1
IpecacACTIVE INGREDIENT62I3C8233L1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
PodophyllumACTIVE INGREDIENT2S713A4VP31
RadishACTIVE INGREDIENTEM5RP354631
Rancid BeefACTIVE INGREDIENT29SUH5R3HU1
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Activated CharcoalACTIVE MOIETY2P3VWU3H101
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y1
BilberryACTIVE MOIETY9P2U39H18W1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Citrullus Colocynthis Fruit PulpACTIVE MOIETY23H32AOH171
Collinsonia Canadensis RootACTIVE MOIETYO2630F3XDR1
Ecballium Elaterium FruitACTIVE MOIETY8P8HWT6ZWC1
English WalnutACTIVE MOIETY1V3SHR7QB71
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GingerACTIVE MOIETYC5529G5JPQ1
Horse ChestnutACTIVE MOIETY3C18L6RJAZ1
IpecacACTIVE MOIETY62I3C8233L1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
PodophyllumACTIVE MOIETY2S713A4VP31
RadishACTIVE MOIETYEM5RP354631
Rancid BeefACTIVE MOIETY29SUH5R3HU1
Silver CationACTIVE MOIETY57N7B0K90A1
Tobacco LeafACTIVE MOIETY6YR2608RSU1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-801455714-8014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Rancid Beef29SUH5R3HUACTIB
Aconitum NapellusU0NQ8555JDACTIB
Silver Nitrate95IT3W8JZEACTIB
Arsenic TrioxideS7V92P67HOACTIM
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
RadishEM5RP35463ACTIB
Tobacco Leaf6YR2608RSUACTIB
Bilberry9P2U39H18WACTIB
GingerC5529G5JPQACTIB
Horse Chestnut3C18L6RJAZACTIB
English Walnut1V3SHR7QB7ACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 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
61febc3a-7ba9-6691-2b5b-89f1f8d10c15c0d1d114-7e8c-b7ed-f421-ba8d3c305a9e2014-04-15WarningsExact identifier
spl id: 61febc3a-7ba9-6691-2b5b-89f1f8d10c15
spl set id: c0d1d114-7e8c-b7ed-f421-ba8d3c305a9e

Reported adverse events (FAERS/openFDA)#

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