FDA.reportPublic FDA data

Drainer

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:43

Label at a glance#

ProductDrainer
Active ingredientCYNARA SCOLYMUS LEAF, BENZOIC ACID, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CENTAUREA BENEDICTA, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, DIOSCOREA VILLOSA TUBER, CHIONANTHUS VIRGINICUS BARK, MUCUNA PRURIENS FRUIT TRICHOME, IRIS VERSICOLOR ROOT, JUNIPER BERRY, STRYCHNOS NUX-VOMICA SEED, PTELEA TRIFOLIATA BARK, TARAXACUM OFFICINALE, URIC ACID, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination..

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) at bedtime or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Cynara scolymus 6x, Solidago virgaurea 6x, Taraxacum officinale 6x, Benzoicum acidum 15x, Berberis vulgaris 15x, Bryonia 15x, Cantharis 15x, Carduus benedictus 15x, Carduus marianus 15x, Ceanothus americanus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona officinalis 15x, Dioscorea villosa 15x, Dolichos pruriens 15x, Iris versicolor 15x, Juniperus communis 15x, Nux vomica 15x, Ptelea trifoliata 15x, Taraxacum officinale 15x, Uricum acidum 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

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 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4793-1Drainer30 g in 1 BOTTLE, GLASSPELLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4793DRAINER (CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201203_9a008b9f-5db5-fac0-e053-2995a90a17c6.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-479355714-4793-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
CYNARA SCOLYMUS LEAFB71UA545DEACTIB
BENZOIC ACID8SKN0B0MIMACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
MILK THISTLEU946SH95EEACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
MUCUNA PRURIENS FRUIT TRICHOME3E271BSI0CACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
JUNIPER BERRYO84B5194RLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PTELEA TRIFOLIATA BARK5KQR6FTT0DACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
URIC ACID268B43MJ25ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB

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
DrainerCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Newton Laboratories, Inc.9a008b9f-5db5-fac0-e053-2995a90a17c62020-12-02WarningsExact identifier
ndc (package): 55714-4793-1
ndc (product): 55714-4793
ndc11 (package): 55714479301
spl id: b5836d3e-1725-5a73-e053-2995a90a607d
spl set id: 9a008b9f-5db5-fac0-e053-2995a90a17c6

Reported adverse events (FAERS/openFDA)#

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