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

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.

----------

SleepCalm Kids

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*

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

Uses*

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

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

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.

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.

alcohol, purified water,

BoironUSA.com Info@boiron.com

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

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

labellabellabellabel

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)

Revised: 11/2023
Document Id: 0992dcf6-0f08-c4e5-e063-6294a90a6bd1
Set id: aef7b774-355a-3fb8-e053-2a95a90a268c
Version: 5
Effective Time: 20231107
 
Boiron