Label: SYMPHYTUM OFFICINALE pellet

  • NDC Code(s): 55714-7521-1
  • 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 18, 2020

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

    Bone injuries; Eye injuries; Sprains; Bruises; Joint pain.

  • 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 purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Symphytum officinale 15x, 10x, 200c, 30c.

  • OTC - PURPOSE SECTION

    Bone injuries; Eye injuries; Sprains; Bruises; Joint pain.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 1.800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

  • 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
    SYMPHYTUM OFFICINALE 
    symphytum officinale pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-7521
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT15 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-7521-128 g 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(55714-7521)