FDA.reportPublic FDA data

MacDee

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:53

Label at a glance#

ProductMacDee
Active ingredientACONITUM NAPELLUS, BARIUM CARBONATE, ATROPA BELLADONNA, CROTALUS HORRIDUS HORRIDUS VENOM, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, LACHESIS MUTA VENOM, MERCURY, PHOSPHORUS, PICRIC ACID, LEAD, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, DATURA STRAMONIUM, THERIDION CURASSAVICUM, MICRURUS CORALLINUS VENOM, GOLD
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as blurry vision, loss of night vision and trouble discerning colors.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aconitum napellus 15x, Aurum metallicum 15x, Baryta carbonica 15x, Belladonna 15x, Crotalus horridus 15x, Euphrasia officinalis 15x, Gelsemium sempervirens 15x, Hamamelis virginiana 15x, Lachesis mutus 15x, Mercurius vivus 15x, Phosphorus 15x, Picricum acidum 15x, Plumbum metallicum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Stramonium 15x, Theridion 15x, Elaps corallinus 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such as blurry vision, loss of night vision and trouble discerning colors.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4827-1MacDee30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4827MACDEE (ACONITUM NAPELLUS, AURUM METALLICUM, BARYTA CARBONICA, BELLADONNA, CROTALUS HORRIDUS, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, MERCURIUS VIVUS, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, PULSATILLA, RHUS TOXICODENDRON, STRAMONIUM, THERIDION, ELAPS CORALLINUS.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201205_9a6409d4-89f3-1ab8-e053-2995a90a3f1f.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
55714-482755714-4827-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURYFXS1BY2PGLACTIB
PHOSPHORUS27YLU75U4WACTIB
PICRIC ACIDA49OS0F91SACTIB
LEAD2P299V784PACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GOLD79Y1949PYOACTIB

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
MacDeeACONITUM NAPELLUS, AURUM METALLICUM, BARYTA CARBONICA, BELLADONNA, CROTALUS HORRIDUS, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, MERCURIUS VIVUS, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, PULSATILLA, RHUS TOXICODENDRON, STRAMONIUM, THERIDION, ELAPS CORALLINUS.Newton Laboratories, Inc.9a6409d4-89f3-1ab8-e053-2995a90a3f1f2020-12-04WarningsExact identifier
ndc (package): 55714-4827-1
ndc (product): 55714-4827
ndc11 (package): 55714482701
spl id: b5aaba49-f865-3b55-e053-2995a90abcf4
spl set id: 9a6409d4-89f3-1ab8-e053-2995a90a3f1f

Reported adverse events (FAERS/openFDA)#

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