Label: FLU CARE- influenza a virus, influenza b virus, histaminum hydrochloricum, aconitum nap., aralia quinquefolia, arsenicum alb., baptisia, bryonia, cinchona, eupatorium perf., gelsemium, ipecac., kali carb., nux vom., phosphorus, rhus toxicodendron, echinacea pellet

  • NDC Code(s): 55714-2443-1
  • 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 November 25, 2020

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, vomiting, cramping and other related symptoms.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purfied water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Echinacea 6x, Aconitum napellus 10x, Aralia quinquefolia 10x, Baptisia tinctoria 10x, Bryonia 10x, Cinchona officinalis 10x, Eupatorium perfoliatum 10x, Gelsemium sempervirens 10x, Ipecacuanha 10x, Kali carbonicum 10x, Phosphorus 10x, Rhus toxicodendron 10x, Arsenicum album 15x, Histaminum hydrochloricum 15x, Nux vomica 15x, Influenzinum 30x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, vomiting, cramping and other related symptoms.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactrose-free) pellets.

  • 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
    FLU CARE 
    influenza a virus, influenza b virus, histaminum hydrochloricum, aconitum nap., aralia quinquefolia, arsenicum alb., baptisia, bryonia, cinchona, eupatorium perf., gelsemium, ipecac., kali carb., nux vom., phosphorus, rhus toxicodendron, echinacea pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2443
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS30 [hp_X]  in 1 g
    INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA B VIRUS30 [hp_X]  in 1 g
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 g
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 1 g
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG10 [hp_X]  in 1 g
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 g
    BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA10 [hp_X]  in 1 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 g
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP10 [hp_X]  in 1 g
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 1 g
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC10 [hp_X]  in 1 g
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [hp_X]  in 1 g
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 g
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1 g
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2443-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2443)
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