FDA.reportPublic FDA data

Simply Shift

Manufacturer
Nartex Laboratorios Homeopaticos, S.A. De C.V.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:46:44

Label at a glance#

ProductSimply Shift
Active ingredientARNICA MONTANA, VALERIAN, PASSIFLORA INCARNATA FLOWERING TOP
Label structure9 sections

Indications and 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.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Passiflora incarnata1X HPUS*

Valeriana officinalis1X HPUS*

Arnica montana12X HPUS*

Purpose

OTC - PURPOSE SECTION

Passiflora incarnata1X HPUS*......................Sleeplessness from worries and restlessness

Valeriana officinalis1X HPUS*.......................Restless sleep

Arnica montana12X 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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • 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.

OTC - DO NOT USE SECTION

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.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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.

PACKAGE LABEL.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

11

22

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-40434666-404-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
SODIUM BENZOATEOJ245FE5EUIACT
GELATIN2G86QN327LIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
WATER059QF0KO0RIACT
TALC7SEV7J4R1UIACT
STARCH, POTATO8I089SAH3TIACT
ARNICA MONTANAO80TY208ZWACTIB
VALERIANJWF5YAW3QWACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2918cd37-e542-cf6d-e063-6394a90aed8cd24517c9-11d7-28f5-e053-2995a90a01962024-12-12WarningsExact identifier
spl id: 2918cd37-e542-cf6d-e063-6394a90aed8c
spl set id: d24517c9-11d7-28f5-e053-2995a90a0196

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.