Label: SLEEPCALM KIDS- matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium liquid
- NDC Code(s): 0220-9309-07, 0220-9309-09
- Packager: 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 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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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
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLEEPCALM KIDS
matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9309 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 9 [hp_C] POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 9 [hp_C] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_C] MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 9 [hp_C] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 9 [hp_C] HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 9 [hp_C] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9309-09 1 in 1 BOX 09/10/2020 1 15 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0220-9309-07 5 in 1 POUCH; Type 0: Not a Combination Product 04/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/10/2020 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 383674934 manufacture(0220-9309)