Label: MACDEE- 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

  • NDC Code(s): 55714-4827-1
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 4, 2020

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  • 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

    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

  • INGREDIENTS AND APPEARANCE
    MACDEE 
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4827
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE15 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 mL
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK15 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID15 [hp_X]  in 1 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD15 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM15 [hp_X]  in 1 mL
    THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM15 [hp_X]  in 1 mL
    MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM30 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4827-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/02/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-4827)
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