HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) LIQUID [NEWTON LABORATORIES, INC.]

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HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) LIQUID [NEWTON LABORATORIES, INC.]
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NDC 55714-6275-1
Set ID 1ba00a48-5d03-89ba-2ffa-29add3ba5996
Category HUMAN OTC DRUG LABEL
Packager Newton Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • INDICATIONS & USAGE SECTION

    Nerve pain and injury, Puncture wounds, Neuralgia.

  • 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.

  • OTC - ACTIVE INGREDIENT SECTION

    Hypericum perforatum 15x; Hypericum perforatum 200c

  • OTC - PURPOSE SECTION

    Nerve pain and injury, Puncture wounds, Neuralgia.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 1.800.448.7256

    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
    HYPERICUM PERFORATUM 
    hypericum perforatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-6275
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-6275-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-6275)
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