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

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]

Homeopathic Liquid Attenuations ACTIVE INGREDIENTS HPUS

Passiflora incarnata 2X

Valeriana officinalis 2X

Avena sativa 2X

Cuprum aceticum 9X

Hyoscyamus niger 9X

Alcohol 13 %

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: 15-20 drops under the tongue or in a teaspoonful of water 3 times a day. 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

1-800-404-4666

CARTON

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-2008
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]  in 30 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	2 [hp_X]  in 30 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]  in 30 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	9 [hp_X]  in 30 mL
HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E)	HYOSCYAMUS NIGER WHOLE	9 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-2008-4	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/11/2013

Labeler - HOMEOLAB USA INC. (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC.		202032533	manufacture(60512-2008)