SLEEPCALM- hyoscyamus niger, nutmeg, 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 Pellets

Active ingredients** (in each pellet)

Hyoscyamus niger 3C HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids)

Nux moschata 4C HPUS (0.11 mg)

Passiflora incarnata 3X HPUS (0.11 mg)

Stramonium 6X HPUS (0.11 mg) (contains less than 10 -9 mg atropine alkaloids)

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

Hyoscyamus niger 3C HPUS (0.11 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.11 mg) ... Relieves restless sleep

Passiflora incarnata 3X HPUS (0.11 mg) ... Relieves sleeplessness associated with worries and exhaustion

Stramonium 6X HPUS (0.11 mg) ... Relieves sleeplessness with intermittent awakening

Uses*

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.

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

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

Directions

lactose, sucrose

BoironUSA.com

Info@Boiron.Com

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA 19073

Melatonin-Free

Sleep Relief*

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

Calms Restless Mind*

No Known Drug Interactions

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Tube - Contains approx. 80 pellets, 3.8g, (0.13 oz)

Tube - Do not use if pellet dispenser seal is broken.

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.

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SLEEPCALM 
hyoscyamus niger, nutmeg, passiflora incarnata flowering top, datura stramonium pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [hp_C]
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_X]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [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:0220-9311-422 in 1 BOX04/27/2022
1NDC:0220-9311-4180 in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/27/2022
Labeler - Boiron (282560473)
Registrant - Boiron, Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Boiron282560473manufacture(0220-9311)

Revised: 4/2024
Document Id: 16c77587-39d7-31cf-e063-6294a90a7f22
Set id: dda7a51d-7c2c-67f4-e053-2a95a90a8e72
Version: 3
Effective Time: 20240423
 
Boiron