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

Hyoscyamus niger 3C HPUS (0.6 mg)** (contains less than 10 -11mg alkaloids)
Nux moschata 4C HPUS (0.6 mg)**
Passiflora incarnata 3X HPUS (0.6 mg)**
Stramonium 6X HPUS (0.6 mg)** (contains less than 10- 8 mg alkaloids)

(in each tablet)

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 (0.6 mg)* .. Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.6 mg)* ... Relieves restless sleep
Passiflora incarnata 3X HPUS (0.6 mg)* ... Relieves sleeplessness associated with worries and exhaustion
Stramonium 6X HPUS (0.6 mg)* .. Relieves sleeplessness with intermittent awakening

Temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening, helps reduce difficutly 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 breastfeeding, ask a health professional before use.

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

Adults and children 12 years of age and older: Allow 2 tablets to dissolve under the tongue 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 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.

No known drug interactions

No artificial colors, flavors or sweeteners

Plant based actives

No daytime grogginess

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

LABELlabel

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
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: 12/2020
 
Laboratoires Boiron