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  5. Label Information: Quietude

FDA Label for Quietude

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - DO NOT USE
    4. DOSAGE & ADMINISTRATION
    5. INACTIVE INGREDIENT
    6. HOW SUPPLIED
    7. OTC - PURPOSE
    8. STORAGE AND HANDLING
    9. OTC - QUESTIONS
    10. OTC - ASK DOCTOR
    11. OTC - STOP USE
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OTC - PREGNANCY OR BREAST FEEDING
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quietude Product Label

The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Indications & Usage



Temporary relieves occasional sleeplessness and/or restless sleep


Otc - 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


Otc - 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)


Otc - Questions



Questions, Comments
www.boironusa.com
[email protected]

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


Otc - Ask Doctor



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


Otc - 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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Otc - Pregnancy Or Breast Feeding



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


Package Label.Principal Display Panel



Quietude image

Quietude Image - box

Quietude Image - box


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