Label: TERRAVITALS BAKNEK- zincum metallicum, lecithinum pellet

  • 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 August 15, 2021

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

  • Terravitals Active Ingredients

    Active ingredients .. Purpose **

    Zincum metallicum 30C HPUS................................hard stool, small rather dry

    Lecithin 30C HPUS .................................................bloating

    ** C' is homeopathic dilution.

    'HPUS' indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

    Internal small package:

    Internal label constip

  • Terravitals Purpose

    Active ingredients .. Purpose **

    Zincum metallicum 30C HPUS................................hard stool, small rather dry

    Lecithin 30C HPUS ................................................ bloating

    **'C' is homeopathic dilution.

    'HPUS' indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States

    * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Terravitals Warnings

    Warnings Stop use and ask a doctor If symptoms persist more than 5 days or worsen. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Directions - Adults and adolescents 12 and over: Dissolve 1-2 pellets in mouth once a day before bedtime, until symptoms are relieved.

  • Terravitals Dosage

    Oral soluble pellets

  • Terravitals Other

    Other information: Store in a dry place between 15-30°C (59-86°F) and out of direct sunlight.

  • DO NOT USE

    Do not use if the seal of pellet dispenser inside is missing or broken.

  • Terravitals BakNek Inactive Ingredient

    Inactive ingredient Organic Sucrose certified by DE-OKO-070. (Organic logo)

  • Terravitals main panel

    TERRAVITALS BakNek

    Homeopathic Medicine

    Relieves occasional constipation*

    NDC 74474-401-01

    Approx 75 Oral soluble pellets

    Non-drowsy

    Not habit-forming

    No drug interactions

    No known side effects

    Made in the USA by Terravitals LLC, Gaithersburg MD 20879

    www.terravitals.com

    Exp: MM/YYYY

    Lot: CTYYADDXX

    Outer packaging label:

    External label Constip

  • INGREDIENTS AND APPEARANCE
    TERRAVITALS BAKNEK 
    zincum metallicum, lecithinum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74474-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) (LECITHIN, SOYBEAN - UNII:1DI56QDM62) LECITHIN, SOYBEAN30 [hp_C]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White spheroids) Score    
    ShapeSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74474-401-011 in 1 TUBE08/15/2021
    11 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/2021
    Labeler - Terravitals LLC (117322434)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terravitals LLC117322434manufacture(74474-401)