QUIETUDE- hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet

Quietude by

Drug Labeling and Warnings

Quietude by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

Temporary relieves occasional sleeplessness and/or restless sleep

DO NOT USE

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Croscarmellose sodium, lactose, magnesium stearate

HOW SUPPLIED

60 tablets

PURPOSE

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.

STORAGE AND HANDLING

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

QUESTIONS

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

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

STOP USE

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

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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

WARNINGS

PRINCIPAL DISPLAY PANEL

Quietude image

INGREDIENTS AND APPEARANCE

QUIETUDE 
hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	3 [hp_C]
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	4 [hp_C]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	3 [hp_X]
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (BOIRON)	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9314-04	60 in 1 BOX; Type 0: Not a Combination Product	10/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/01/2013

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9314)