SLEEPCALM- matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium pellet 
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.

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SleepCalm Kids Pellet

Active ingredients** (in each pellet)

Chamomilla 9C HPUS (0.07 mg)

Gelsemium sempervirens 9C HPUS (0.07 mg)(contains less than 10 -21 mg gelsemine)

Hyoscyamus niger 9C HPUS (0.07 mg)(contains less than 10 -22 mg atropine alkaloids)

Kali bromatum 9C HPUS (0.07 mg)(contains less than 10 -19 mg bromide)

Passiflora incarnata 3C HPUS (0.07 mg)

Stramonium 9C HPUS (0.07 mg)(contains less than 10 -21 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*

Relieves Occasional Sleeplessness, Restless Sleep, Intermittent Awakening, Irritability, and Nightmares

Uses*

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

Stop 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

lactose, sucrose

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Melatonin-Free

Kids Sleep Aid*

Restores a Natural Sleep Pattern

Tubes - contains approx. 80 pellets, 3.8g (0.13 oz)

Turn tube upside down, Twist until 5 pellets are dispensed, Remove cap and pour pellets under the tongue

*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.

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

labellabel

SLEEPCALM 
matricaria chamomilla whole, gelsemium sempervirens root, hyoscyamus niger, potassium bromide, passiflora incarnata flowering top, datura stramonium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT9 [hp_C]
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE9 [hp_C]
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER9 [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]
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM9 [hp_C]
Inactive Ingredients
Ingredient NameStrength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0220-9308-422 in 1 BOX05/02/2022
1NDC:0220-9308-4180 in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/02/2022
Labeler - Boiron (282560473)
Registrant - Boiron, Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Boiron282560473manufacture(0220-9308)

Revised: 9/2023
Document Id: 05b737df-3c6c-f84e-e063-6394a90a570d
Set id: de0b458d-5f0a-78f4-e053-2995a90afe4b
Version: 2
Effective Time: 20230919
 
Boiron