SIMPLY SHIFT- passiflora incarnata, valeriana officinalis, arnica montana tablet

Simply Shift by

Drug Labeling and Warnings

Simply Shift by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos, S.A. De C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlining medical illness.
• Do not take this product for pain for more than 10 days unless directed by a doctor. If pain persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

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

• adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
• children under 12 years, consult a physician.

Other information

• store in a cool and dry place.
• do not use if container seal is broken.

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.

PRINCIPAL DISPLAY PANEL

NDC: 34666-404-01

SIMPLY Shift

Sleep Cycle Restoration

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

• Feel refreshed and rested
• Stay Calm
• Reduce fatigue and lethargy

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

Homeopathic

Nighttime sleep aid

120 Tablets

INGREDIENTS AND APPEARANCE

SIMPLY SHIFT 
passiflora incarnata, valeriana officinalis, arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-404
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	12 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	LogoNartex
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-404-01	1 in 1 CARTON	12/03/2021
1		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/03/2021

Labeler - Nartex Laboratorios Homeopaticos, S.A. De C.V. (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos, S.A. De C.V.		589914576	manufacture(34666-404)