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Quietude

Laboratoires Boiron
Boiron Inc.

Consumer Label Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

Uses

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

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.

Store at 68-77o F (20-25o 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.

Quietude image Quietude

Quietude

HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0220-9314
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hyoscyamus Niger HYOSCYAMUS NIGER 3 [hp_C]
NUTMEG NUTMEG 4 [hp_C]
PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP 3 [hp_X]
DATURA STRAMONIUM DATURA STRAMONIUM 6 [hp_X]

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE
MAGNESIUM STEARATE

Product Characteristics

Color Size Shape
white 9 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0220-9314-04 60 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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