Terravitals MidBak by Terravitals LLC

Terravitals MidBak by

Drug Labeling and Warnings

Terravitals MidBak by is a Homeopathic medication manufactured, distributed, or labeled by Terravitals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TERRAVITALS MIDBAK- chamomile,rutagraveolens,zinc,veratrumalbum pellet 
Terravitals LLC

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.

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Terravitals MidBak Active Ingredients

Active ingredients

Chamomile 30C HPUS

Ruta graveolens 6C HPUS

Veratrum album 30C HPUS

Zincum metallicum 30C HPUS

Internal packaging:

Terravitals MidBak Purpose

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

Chamomile 30C 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.

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 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: 74474-104-01

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:

TERRAVITALS MIDBAK 
chamomile,rutagraveolens,zinc,veratrumalbum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74474-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C]
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_C]
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	30 [hp_C]
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (White spheroids)	Score
Shape		Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74474-104-01	1 in 1 TUBE	06/15/2021
1		1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2021	06/15/2021

Labeler - Terravitals LLC (117322434)

Establishment
Name	Address	ID/FEI	Business Operations
Terravitals LLC		117322434	manufacture(74474-104)

Revised: 6/2021

Document Id: c535d812-27f3-fbc2-e053-2995a90a7c7e

34390-5

Set id: c493f814-a6fd-9540-e053-2a95a90a9af1

Version: 2

Effective Time: 20210620