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

  • NDC Code(s): 0220-9310-04, 0220-9310-29, 0220-9310-91
  • Packager: Laboratoires Boiron
  • 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 6, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients** (in each tablet)

    Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids)
    Nux moschata 4C HPUS (0.63 mg)
    Passiflora incarnata 3X HPUS (0.63 mg)
    Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids)

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness

    Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep
    Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion
    Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening

    helps reduce difficulty falling asleep due to: nervousness, worries

  • WARNINGS

  • ASK DOCTOR

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime.

    Children under 12 of age: Ask a doctor.

  • SPL UNCLASSIFIED SECTION

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

    store below 86 oF (30 oC)

    Contains 20 meltaway tablets

    Contains 60 meltaway tablets

    Contains 120 meltaway tablets

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    **C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

    Calms Restless Mind*

    No Known Drug Interactions

    Non-habit forming

    No artificial sweetners or flavors

    Gluten-free

    Melatonin-Free

    Sleep Relief*

  • INACTIVE INGREDIENT

    croscarmellose sodium, lactose, magnesium stearate

  • QUESTIONS

    BoironUSA.com

    Info@boiron.com

    1-800-BOIRON-1 (1-800-264-7661)

    Made in France

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabellabelLabellabellabelLABELlabel

  • INGREDIENTS AND APPEARANCE
    SLEEPCALM 
    hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [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]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9310-041 in 1 PACKAGE04/01/2020
    160 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0220-9310-291 in 1 PACKAGE12/11/2020
    2120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0220-9310-911 in 1 PACKAGE07/12/2021
    320 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2020
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9310)
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