Label: SYMPHYTUM OFFICINALE- comfrey granule

  • Category: HUMAN OTC DRUG LABEL

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 October 5, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    SYMPHYTUM OFFICINALE (Comfrey) 200K GR

    SYMPHYTUM OFFICINALE (Comfrey) 30CH GR

    SYMPHYTUM OFFICINALE (Comfrey) 30K GR

    SYMPHYTUM OFFICINALE (Comfrey) 5CH GR

    SYMPHYTUM OFFICINALE (Comfrey) 6CH GR

    SYMPHYTUM OFFICINALE (Comfrey) 7CH GR

    SYMPHYTUM OFFICINALE (Comfrey) MK GR

  • PURPOSE

    Indications

    Helps to relieve gastric upsets and muscle ache

  • WARNINGS

    Warning

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose,

    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    Helps to relieve gastric upsets and muscle ache

    Directions:

    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-9001

    UNDA

    Do not use if label perforation is broken

    Homeopathic Remedy

    NDC : 62106-9001-4

    SYMPHYTUM OFFICINALE

    Comfrey

    140 granules

    Indications

    Helps to relieve gastric upsets and muscle ache

  • INGREDIENTS AND APPEARANCE
    SYMPHYTUM OFFICINALE 
    comfrey granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-9001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-9001-410 in 1 CARTON01/30/201505/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/30/201505/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-9001)