Label: TERRAVITALS MIDBAK- chamomile,rutagraveolens,zinc,veratrumalbum pellet

  • 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 June 26, 2021

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

  • Terravitals MidBak Active Ingredients

    Active ingredients

    Chamomile 6C HPUS

    Ruta graveolens 6C HPUS

    Veratrum album 30C HPUS

    Zincum metallicum 30C HPUS

    Internal packaging:

    Internal label MidBak

  • Terravitals MidBak Purpose

    Active ingredients** .............................…..............................….Purpose

    Chamomile 6C HPUS...........painful pressure middle and dorsal spine

    Ruta graveolens 6C HPUS.........backache better when resting on back

    Veratrum album 30C HPUS...................pain on scapular region of back

    Zincum metallicum 30C HPUS.........pressure in the middle of the spine

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

    **'C' is homeopathic dilution.

    Uses* For temporary relief of pressure on the middle of spine and of dorsal pain, due to minor muscle strain.

    **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 at the onset of symptoms, repeat every 1- 6 hours as needed

  • 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 Inactive Ingredient

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

  • Terravitals MidBak main panel

    TERRAVITALS MidBak

    Homeopathic Medicine

    Relieves middle back pain*

    NDC 74474-105-01

    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: YYADXX

    Outer packaging label:

    External label MidBak

  • INGREDIENTS AND APPEARANCE
    TERRAVITALS MIDBAK 
    chamomile,rutagraveolens,zinc,veratrumalbum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74474-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_C]
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_C]
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT30 [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:74474-105-011 in 1 TUBE06/26/2021
    11 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/26/2021
    Labeler - Terravitals LLC (117322434)
    Establishment
    NameAddressID/FEIBusiness Operations
    Terravitals LLC117322434manufacture(74474-105)