Label: FEVER - INFECTION- anthracinum, influenza a virus, influenza b virus, pyrogenium, aconitum nap., antimon. tart., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chamomilla, cinchona, eupatorium perf., ferrum metallicum, gelsemium, hepar sulph.calc., iodium, lachesis, merc. viv., phosphorus, pulsatilla, rhus toxicodendron, salix nigra, verbascum, apis mel., echinacea, hydrastis liquid

  • NDC Code(s): 55714-2440-0, 55714-2440-1, 55714-2440-2
  • 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 January 9, 2020

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  • INDICATIONS & USAGE SECTION

    Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed health professional.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Apis mel. 6x, Echinacea 6x, Hydrastis 6x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salix nigra 15x, Verbascum 15x, Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

  • 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.

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

  • 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
    FEVER - INFECTION 
    anthracinum, influenza a virus, influenza b virus, pyrogenium, aconitum nap., antimon. tart., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chamomilla, cinchona, eupatorium perf., ferrum metallicum, gelsemium, hepar sulph.calc., iodium, lachesis, merc. viv., phosphorus, pulsatilla, rhus toxicodendron, salix nigra, verbascum, apis mel., echinacea, hydrastis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2440
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT30 [hp_X]  in 1 mL
    INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS30 [hp_X]  in 1 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF30 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE15 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA15 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA15 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA15 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]  in 1 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE15 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE15 [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
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS15 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK15 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS15 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2440-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2019
    2NDC:55714-2440-250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201907/31/2019
    3NDC:55714-2440-00.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201907/31/2019
    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(55714-2440)
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