Label: QUIETUDE- hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet

  • 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 November 29, 2023

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  • ACTIVE INGREDIENT

    Hyoscyamus niger 3C, Nux moschata 4C, Passiflora incarnata 3X, Stramonium 6X

  • INDICATIONS & USAGE

    Temporary relieves occasional sleeplessness and/or restless sleep

  • DO NOT USE

    Do not use if glued carton end flaps are open or if the blister seal is broken

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth 3 hours before bedtime. Then, dissolve 2 tablets in the mouth at bedtime.
    Children under 12 years of age: Ask a doctor

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate

  • HOW SUPPLIED

    60 tablets

  • PURPOSE

    Hyoscyamus niger 3C ... Relieves restless sleep associated with nervousness
    Nux moschata 4C... Relieves restless sleep
    Passiflora incarnata 3X... Relieves sleeplessness associated with worries and exhaustion.
    Stramonium 6X ... Relieves sleeplessness with intermittent awakening.

  • STORAGE AND HANDLING

    Store at 68-77 o F (20-25 o C)

  • QUESTIONS

    Questions, Comments
    www.boironusa.com
    info@boironusa.com

    1-800-BOIRON-1
    (1-800-264-7661)
    Distributed by Boiron Inc.
    6 campus boulevard
    Newtown Square, PA
    19073-3267

  • ASK DOCTOR

    Ask doctor before use in children under 12 years of age.

  • STOP USE

    Stop use and ask a doctor if symptoms persists continuously for more than 2 weeks or worsen. Insomnia may be a symptom of a serious underlying illness.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

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

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    boxQuietude image Quietude Image

  • INGREDIENTS AND APPEARANCE
    QUIETUDE 
    hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [hp_C]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [hp_C]
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (BOIRON) Size9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9314-0460 in 1 BOX; Type 0: Not a Combination Product10/01/201310/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/201310/31/2024
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9314)
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