Label: SLEEPCALM KIDS- matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium liquid

  • 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 7, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients** (in each 1 mL vial)

    Chamomilla 9C HPUS (0.17 mL)

    Gelsemium sempervirens 9C HPUS (0.17 mL) (contains less than 10 -17 mg gelsemine alkaloids)

    Hyoscyamus niger 9C HPUS (0.17mL) (contains less than 10 -18 mg atropine alkaloids)

    Kali bromatum 9C HPUS (0.17mL) (contains less than 10 -15 mg bromide)

    Passiflora incarnata 3C HPUS (0.17 mL)

    Starmonium 9C HPUS (0.17 mL) (contains less than 10 -18 mg atropine alkaloids)

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

  • PURPOSE

    Purpose*

    Chamomilla 9C HPUS ... Relieves restlessness, irritability, and crying during sleep

    Gelsemium sempervirens 9C HPUS ... Relieves sleeplessness due to apprehension

    Hyoscyamus niger 9C HPUS ... Relieves irritability and restless sleep associated with nervousness

    Kali bromatum 9C HPUS ... Relieves irritability and restless sleep with night terrors

    Passiflora incarnata 3C HPUS ... Relieves occasional restless sleep

    Starmonium 9C HPUS ... Relieves restless sleep with intermittent awakening, nightmares and night terrors

  • INDICATIONS & USAGE

    Uses*

    • temporarily relieves symptoms of occasional sleeplessness in children associated with upsets, excitement, and schedule changes such as:
    • restless sleep
    • intermittent awakening
    • irritability
    • nightmares
    • night terrors
    • reduces the time to fall asleep if your child has difficulty falling asleep
  • WARNINGS

  • DO NOT USE

    Do not use if your child has a known allergy to any ingredient in this product.

  • STOP USE

    Stop and use and ask a doctor if symptoms persist for more than 3 days or worsen. Insomnia may be a symptom of a serious underlying medical illness.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Children 3 years of age and older: Give 1 dose at bedtime, and again during the night if needed for up to a total of 2 doses per night.

    Tear open the foil pouch at the notched edge. Snap off one pre-measured dose. Twist to open. Squeeze entire contents into mouth.

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact

    do not refrigerate or freeze

    after opening the foil pouch: store unused vials in the foil pouch for no longer than 3 months

    after opening the vial: the product must be used immediately

    after administering: discard vial

    do not reuse

    contains 0.0015% alcohol

    Calms Restless Sleep*

    Kids Sleep Aid*

    Melatonin Free

    15 pre-measured liquid doses

    5 pre-measured liquid doses

    0.34 fl oz (1 mL) each

    99.99% alcohol-free

    Fall Asleep, Stay Asleep

    *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.

  • INACTIVE INGREDIENT

    alcohol, purified water,

  • QUESTIONS

    BoironUSA.com Info@boiron.com

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

    Distributed by Boiron, Inc. Newtown Square, PA 19073

    Made in France

  • PRINCIPAL DISPLAY PANEL

    labellabellabellabel

  • INGREDIENTS AND APPEARANCE
    SLEEPCALM KIDS 
    matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9309
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM9 [hp_C]
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE9 [hp_C]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_C]
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE9 [hp_C]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT9 [hp_C]
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER9 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9309-091 in 1 BOX09/10/2020
    115 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0220-9309-075 in 1 POUCH; Type 0: Not a Combination Product04/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/10/2020
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron383674934manufacture(0220-9309)