Label: SIMPLY SHIFT- passiflora incarnata, valeriana officinalis, arnica montana tablet
- NDC Code(s): 34666-404-01
- Packager: Nartex Laboratorios Homeopaticos, S.A. De C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 December 3, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
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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.
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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.
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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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
SIMPLY SHIFT
passiflora incarnata, valeriana officinalis, arnica montana tabletProduct 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)