Label: SIMPLY DREAMS- passiflora incarnata, valeriana officinalis tablet

  • NDC Code(s): 34666-402-01
  • 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.

  • Active ingredients

    Passiflora incarnata 1X HPUS*

    Valeriana officinalis 1X HPUS*

  • Purpose

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

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

    *The letters "HPUS" indicate that the components 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

    Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. 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 underlying medical illness.

    Do not use

    • if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.
    • for children under 12 years of age.

    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 2 tablets every 24 hours. Dissolves slowly in mouth.
    • children under 12 years, do not use.
  • 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 34666-402-01

    SIMPLY Dreams

    Nighttime Sleep Aid

    • Helps falling asleep naturally
    • No day-time grogginess
    • Calms restless sleep

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

    Homeopathic

    80 Tablets

    1

    2

  • INGREDIENTS AND APPEARANCE
    SIMPLY DREAMS 
    passiflora incarnata, valeriana officinalis tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-402
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    WATER (UNII: 059QF0KO0R)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code LogoNartex
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-402-011 in 1 CARTON12/03/2021
    180 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(34666-402)