QUIETUDE- 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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Quietude

Hyoscyamus niger 3C, Nux moschata 4C, Passiflora incarnata 3X, Stramonium 6X

Temporary relieves occasional sleeplessness and/or restless sleep

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

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth 3 hours before bedtime. Then, dissolve 2 tablets in the mouth at bedtime.
Children under 12 years of age: Ask a doctor

Croscarmellose sodium, lactose, magnesium stearate

60 tablets

Hyoscyamus niger 3C ... Relieves restless sleep associated with nervousness
Nux moschata 4C... Relieves restless sleep
Passiflora incarnata 3X... Relieves sleeplessness associated with worries and exhaustion.
Stramonium 6X ... Relieves sleeplessness with intermittent awakening.

Store at 68-77 o F (20-25 o C)

Questions, Comments
www.boironusa.com
info@boironusa.com

1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 campus boulevard
Newtown Square, PA
19073-3267

Ask doctor before use in children under 12 years of age.

Stop use and ask a doctor if symptoms persists continuously for more than 2 weeks or worsen. Insomnia may be a symptom of a serious underlying illness.

Keep out of reach of children

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

boxQuietude image Quietude Image

QUIETUDE 
hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER3 [hp_C]
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [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]
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (BOIRON) Size9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0220-9314-0460 in 1 BOX; Type 0: Not a Combination Product10/01/201310/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/201310/31/2024
Labeler - Laboratoires Boiron (282560473)
Registrant - Boiron Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Boiron282560473manufacture(0220-9314)

Revised: 11/2023
Document Id: 0b51dae5-fa5b-71d2-e063-6294a90a9a66
Set id: 3d60388b-7457-4217-b487-fdbc996760b5
Version: 6
Effective Time: 20231129
 
Laboratoires Boiron