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

INSOMNIA RELIEF by

Drug Labeling and Warnings

INSOMNIA RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS HPUS

Passiflora incarnata 2X

Valeriana officinalis 2X

Avena sativa 2X

Cuprum aceticum 9X

Hyoscyamus niger 9X

REFERENCES

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

ASK DOCTOR

If symptoms persist or worsen, discontinue use and contact a health professional.

PREGNANCY OR BREAST FEEDING

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

KEEP OUT OF REACH OF CHILDREN

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-0011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA TOP (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 FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	9 [hp_X]
HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E)	HYOSCYAMUS NIGER WHOLE	9 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-0011-1	80 in 1 TUBE; Type 0: Not a Combination Product	10/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/18/2013

Labeler - HOMEOLAB USA INC. (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC.		202032533	manufacture(60512-0011)