INSOMNIA RELIEF- passiflora incarnata, valeriana officinalis, avena sativa, cuprum aceticum, hyoscyamus niger pellet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O), VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW), AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F), CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L), HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E)

Available from:

HOMEOLAB USA INC.

INN (International Name):

PASSIFLORA INCARNATA TOP

Composition:

PASSIFLORA INCARNATA TOP 2 [hp_X]

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Relieves Restlessness, Nervousness and Anxiety Associated with Insomnia This is a natural Homeopathic remedy that relieves restlessness, nervousness and anxiety associated with insomnia.

Authorization status:

unapproved homeopathic

Summary of Product characteristics

INSOMNIA RELIEF- PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA
SATIVA, CUPRUM ACETICUM,
HYOSCYAMUS NIGER PELLET
HOMEOLAB USA INC.
_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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DRUG FACTS
ACTIVE INGREDIENTS HPUS
Passiflora incarnata 2X
Valeriana officinalis 2X
Avena sativa 2X
Cuprum aceticum 9X
Hyoscyamus niger 9X
Manufactured according to the Homeopathic Pharmacopoeia of the United
States (HPUS)
PURPOSE
Relieves Restlessness, Nervousness and Anxiety Associated with
Insomnia
USES
This is a natural Homeopathic remedy that relieves restlessness,
nervousness and anxiety associated
with insomnia.
WARNINGS
If symptoms persist or worsen, discontinue use and contact a health
professional.
As with any drug, if you are pregnant or nursing a baby, seek the
advice of a health professional before
using this product.
Keep this and all medications out of reach of children.
DIRECTIONS
Adults: Allow 3 or 4 pellets to dissolve in mouth one hour before
bedtime. Not for use by children.
OTHER INFORMATION
Do not use if cap seal is broken.
Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2
Canada
PRODUCT OF CANADA
PACKAGE LABELING:
INSOMNIA RELIEF
passiflora incarnata, valeriana officinalis, avena sativa, cuprum
aceticum, hyoscyamus niger pellet
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 0 512-0 0 11
ROUTE OF ADMINISTRATION
ORAL
HOMEOLAB USA INC.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PASSIFLO RA INCARNATA TO P (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA
FLOWERING TOP - UNII:CLF5YFS11O)
PASSIFLORA INCARNATA
TOP
2 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)
VALERIAN
2 [hp_X]
AVENA SATIVA FLO WERING TO P (UNII: MA9 CQJ3F7F) (AVENA SATIVA
FLOWERING
TOP - UNII:MA9 CQJ3F7F)
AVENA SATIVA
FLOWERING TOP
2 [hp_X]
CUPRIC ACETATE (UNII: 39 M11XPH0 3) (CUPRIC CATION - UNII:8 C