SIMPLY SHIFT- passiflora incarnata, valeriana officinalis, arnica montana tablet 
Nartex Laboratorios Homeopaticos, S.A. De C.V.

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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Simply Shift

Active ingredients

Passiflora incarnata 1X HPUS*

Valeriana officinalis 1X HPUS*

Arnica montana 12X HPUS*

Purpose

Passiflora incarnata 1X HPUS*......................Sleeplessness from worries and restlessness

Valeriana officinalis 1X HPUS*.......................Restless sleep

Arnica montana 12X HPUS*...........................Fatigue

*The letters "HPUS" indicate that the compoentns in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Uses

For the temporary relief of fatigue and lethargy and the restoration of a natural sleep pattern disturbed by long commutes, night shifts, travel or Jet Lag. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Warnings

Do not use

  • if you have an allergy or hypersensitivity to the componetns of the formula or have had a prior reaction to this product.

Stop use and ask a doctor if

  • condition worsens.
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
  • rash develops.

If pregnant or breast feeding, consult a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP

Questions or comments?

informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

NDC 34666-404-01

SIMPLY Shift

Sleep Cycle Restoration

associated to long commutes, night shifts, travel or Jet Lag

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evalluated and not clinically tested.

Homeopathic

Nighttime sleep aid

120 Tablets

1

2

SIMPLY SHIFT 
passiflora incarnata, valeriana officinalis, arnica montana tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-404
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, POTATO (UNII: 8I089SAH3T)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize9mm
FlavorImprint Code LogoNartex
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34666-404-011 in 1 CARTON12/03/2021
1120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/03/2021
Labeler - Nartex Laboratorios Homeopaticos, S.A. De C.V. (589914576)
Establishment
NameAddressID/FEIBusiness Operations
Nartex Laboratorios Homeopaticos, S.A. De C.V.589914576manufacture(34666-404)

Revised: 12/2021
Document Id: d24517c9-11d8-28f5-e053-2995a90a0196
Set id: d24517c9-11d7-28f5-e053-2995a90a0196
Version: 1
Effective Time: 20211203
 
Nartex Laboratorios Homeopaticos, S.A. De C.V.