Label: SIMPLY HARMONY- ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tablet

  • NDC Code(s): 34666-403-01
  • 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

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  • Active ingredients

    Ignatia amara 3X HPUS*

    Passiflora incarnata 3X HPUS*

    Valeriana officinalis 3X HPUS*

    Kali phosphoricum 6X HPUS*

  • Purpose

    Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders

    Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness

    Valeriana officinalis 3X HPUS*........................Restless sleep

    Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness

    *The letters "HPUS" indicate that the compoennts 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 mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. 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 components of the formula or have had a prior reaction to this product.

    Stop use and ask a doctor if

    • conditoin 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 34666-403-01

    SIMPLY Harmony

    Mental Fatigue Relief

    • Stay Calm
    • Stay Sharp
    • Stay Focused
    • Mood Support

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

    Homeopathic

    120 Tablets

    1

    2

  • INGREDIENTS AND APPEARANCE
    SIMPLY HARMONY 
    ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-403
    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 TOP3 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE6 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code LogoNartex
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-403-011 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(34666-403)
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