SLEEPCALM- hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet 
Laboratoires 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

Active Ingredients** (in each tablet)

Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids)
Nux moschata 4C HPUS (0.63 mg)
Passiflora incarnata 3X HPUS (0.63 mg)
Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids)

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

Purpose*

Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep
Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion
Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening

Uses*

temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening

helps reduce difficulty falling asleep due to: nervousness, worries

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.

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime.

Children under 12 of age: Ask a doctor.

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 oF (30 oC)

Contains 20 meltaway tablets

Contains 60 meltaway tablets

Contains 120 meltaway tablets

*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.

Calms Restless Mind*

No Known Drug Interactions

Non-habit forming

No artificial sweetners or flavors

Gluten-free

Melatonin-Free

Sleep Relief*

croscarmellose sodium, lactose, magnesium stearate

BoironUSA.com

Info@boiron.com

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

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

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SLEEPCALM 
hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [hp_C]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_X]
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [hp_C]
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0220-9310-041 in 1 PACKAGE04/01/2020
160 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0220-9310-291 in 1 PACKAGE12/11/2020
2120 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0220-9310-911 in 1 PACKAGE07/12/2021
320 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2020
Labeler - Laboratoires Boiron (282560473)
Registrant - Boiron Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Boiron282560473manufacture(0220-9310)

Revised: 11/2023
Document Id: 0981ee4b-1c96-d7a5-e063-6294a90ad203
Set id: a1db8417-baea-6914-e053-2a95a90a2fd3
Version: 5
Effective Time: 20231106
 
Laboratoires Boiron